Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Scrotal ulcer, Skin lesion, Social avoidant behaviour
Clinical narrative: Case number PHHY2015US173497, is an initial spontaneous report from a physician received on 31 Dec 2015 and forwarded by a company (ADR 2016 00029) on 08 Jan 2016. This report refers to a 54 year old male patient. Historical condition was not reported. The pump implanted on 09 Mar 2005 and 05 Dec 2011. The patient underwent dialysis; inguinal lobectomy in 2009 and neck surgery in 2014. Concurrent conditions included quit tobacco in 2009, spinal cord injury, anemia nec, benign hypertension, chronic kidney disease stage III, diabetes type II NIDDM (non insulin dependent diabetes mellitus), diabetes type II uncontrolled, quality insulin dependent, esophageal reflux, hypertension, kidney disease ben without chronic kidney disease, bronchogenic, obstructive sleep apnea, other constipation neurogenic bowel, panic disorder (episodic paroxysmal anxiety) without agoraphobia, paraplegia, complete with spasticity of muscles, paraplegia complete with spasm, pressure ulcer, pressure ulcer of unspecified site stage 1 on scrotum, pressure ulcer stage IV left ischial tuberosity, renal failure on dialysis, renal osteodystrophy, type 2 diabetes mellitus with other specified complication unspecified kidney failure on dialysis, panic disorder episodic paroxysmal anxiety without agoraphobia, paraplegia, complete thoracic 4, drank alcohol rarely, never used illegal drugs and had drug allergy to SEPTRA and Metformin. The patient received LIORESAL intrathecal ampoule 500 ug/ml for the treatment of intractable spasticity from an unknown date at a dose of 140.03 mcg/day. It was reported that the lot number for the new LIORESAL was DS0092AN11; however the lot number for the LIORESAL involved in the event was unknown. The patient also received FLUVIRIN injection from 12 Dec 2013 at an unknown dose. The patient received FLUZONE on 21 Sep 2015 at an unknown dose. The patient received acetylsalicylic acid (manufacturer unknown) 325 mg for the treatment of an unknown indication from an unknown start date at a dose of 1 DF, QD (one tablet daily) (oral). The patient received atorvastatin tablet 10 mg for the treatment of an unknown indication from an unknown date at a dose of 1 DF, QD (one tablet daily) (oral). The patient received Bupropion (unknown manufacturer) tablet 75 mg for the treatment of an unknown indication from an unknown date at a dose of 1 DF, BID (oral). The patient received CALMOSEPTINE for an unknown indication from an unknown date and dose via an unknown route. The patient received gabapentin (unknown manufacturer) capsule 100 mg for an unknown indication from an unknown date and dose via an unknown route. The patient received lisinopril (unknown manufacturer) tablet 40 mg for an unknown from an unknown date at a dose of 1 DF, QD (oral). The patient received lorazepam (unknown manufacturer) tablet 01 mg for the treatment of panic attacks from 03 Dec 2015 at a dose of 1 DF, QHS (1 tablet, at bedtime as needed) via oral route. The patient received pantoprazole (manufacturer unknown) 40 mg for an unknown indication from an unknown start date at a dose of 1 DF, QD (1 delayed release tablet, daily) via oral route. The patient received calcium (manufacturer unknown) tablet 500 mg for an unknown indication from an unknown date at a dose of 1 DF, BID via oral route. The patient received COLACE capsule 100 mg for an unknown indication from an unknown date at a dose of 1 DF, QD via oral route. The patient received COMBIVENT for an unknown indication from an unknown date at a dose of 18 ug to 103 ug/actuation. The patient received NOVOLOG FLEXPEN 100 IU/ml for an unknown indication from an unknown date at a dose of 12 IU, TID, subcutaneously. The patient received oxybutynin chloride (unknown indication) extended release tablet 05 mg for an unknown indication from an unknown date at a dose of 1 DF, QD (oral). CT scan was done on Sep 2010, chest, for lung cancer 2009. Test results showed HgbA1c level 6.5 3 months ago and believed he got one at dialysis, but no results. On 19 Nov 2015, there was a volume discrepancy at the refill. The actual reservoir volume was 10 ml and the expected volume was 1.5 ml. It was noted that the HCP was not aware of any previous volume discrepancies and the pump was refilled and would monitor the situation going forward. No patient symptoms were reported, the patient did not notice a change in therapy over the past refill cycle. Further follow up was done to determine the lot number of the LIORESAL, the cause of the discrepancy, and if any actions or interventions had occurred as a result of the event. Additional information received from a healthcare provider (HCP). No troubleshooting was performed related to the volume discrepancy. The cause of the discrepancy was not determined. The pump was refilled. The patient followed up in the clinic on 24 Sep 2015. The patient had a gradual onset during adulthood of pink blisters on the left scrotum; diagnosed as pressure ulcer of unspecified site, stage 1 on scrotum. The patient and their wife were monitoring it, putting lotion on it that was recommended by the wound nurse and it was healing. Alleviating Factors were peritoneal dialysis, rest, keeping it clean and dry and limiting pressure on it chronic renal failure. The plan was to refill the pump by 17 Nov 2015 and watch the ulcer. The patient followed up in the clinic 19 Nov 2015 for a pump refill. The pump was last filled 14 Sep 2015, 20 ml with same dose. The patient heard an alarm but the HCP did not. It was planned to do the next baclofen refill in Apr (year unspecified). The patient experienced spasticity but it was not painful. It was also noted the patient denied spasms/spasticity. The pump held 40 ml of LIORESAL. The pump was interrogated. The pump was accessed and 10 ml of residual baclofen was removed and replaced with 40 ml of baclofen 500 mcg/ml. The patient did not have increased symptoms. Because there was a large residual of 10 ml, the plan was to monitor the patient and if symptoms develop the pump would be evaluated. Interrogation and update was done with the same dose of 140 mcg/day. The low reservoir alarm date was 02 Apr 2016. The patient followed up with the physician on 03 Dec 2015. The patient complained of skin lesion and had been dealing with some granulation tissue at his catheter insertion site. The patient experienced anxiety that was sudden in onset 02 weeks prior and was ongoing. The frequency of the episodes was daily and increasing. The length of the episodes was 05 minutes. Alleviating factors were deep breathing. Pertinent Findings included avoidance behavior, dizziness with position change, dyspnea, lightheadedness and sweating. The patient denied diaphoresis, feeling of dread and palpitations. The patient had a recent prolonged hospital stay, 11 months including long term acute care, rehabilitation. The patient was currently on dialysis. The patient followed up with a nutritionist for hypoalbuminemia. Action taken with suspect drugs was not reported. The events were assessed as serious (medically significant) by the physician. The outcome and causality of the events were not reported.