Study: NCT00954421

Adverse event: Superficial Wound Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Infection at site of IPG (pulse generator for DBS implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Death
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: drowning due to accident (related to her multiple sclerosis)
Frequency: 1 affected / 13 at risk

Adverse event: Change in mental status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 13 at risk

Adverse event: Exacerbation of Multple Sclerosis symptoms
Serious: yes
Organ System: Nervous system disorders
Notes: affecting facial never numbness (1 case), progressive weakening (2 cases)
Frequency: 1 affected / 13 at risk

Adverse event: Right fractured femur
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Complications with device hardware
Serious: yes
Organ System: Surgical and medical procedures
Notes: fractured DBS cables (1 case), erosion over hardware (1 case)
Frequency: 2 affected / 13 at risk

Adverse event: Implantation of tunneled intrathecal catheter and subcutaneous implantation of a programmable pump
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 13 at risk

Adverse event: Clostridium difficile infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea (1 case), nausea (1 case), vomiting (1 case), constipation (2 cases)
Frequency: 3 affected / 13 at risk

Adverse event: speech difficulty
Serious: no
Organ System: General disorders
Notes: slurred speech (3 cases), slower speech (2 cases), stuttering speech (1 case)
Frequency: 4 affected / 13 at risk

Adverse event: swallowing difficulty
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: facial numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Trigeminal neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 13 at risk

Adverse event: decreased mobility
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: worsened balance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 13 at risk

Adverse event: worsening of nasal allergies
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 13 at risk

Adverse event: pain behind left ear
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: pain under left eye
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: lower breast pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: internal capsule pulling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: pain on left side of head
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 13 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: head pain at crania cap
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: pinching at site of pulse generator
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 13 at risk

Adverse event: Twiddler syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

Adverse event: scar tissue formation at site of DBS
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: irritation at site of pulse generator
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 13 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Eczema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: intra-operative seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 13 at risk

Adverse event: eyelid fluttering
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: tremor in bottom lip
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: tremor in abdomen
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 13 at risk

Adverse event: nocturnal myoclonus of lower extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk