MAUDE Adverse Event Report: ADVANCED NEUROMODULATION SYSTEMS, DBA ST.JUDE MEDICAL NEUROMODULATION DIVISION, ; LIBRAXP NON-RECHARGEABLE IPG

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Nerve Damage (1979); Pain (1994); Deformity/ Disfigurement (2360); Depression (2361); Disability (2371); Cognitive Changes (2551)

Event Date 03/31/2013

Event Type  Injury  

Event Description

On (b)(6) 2012, i had deep brain stimulation device implanted as part of clinical trial to treat severe depression.Three months later, i was experiencing extreme pain on the right side and front of my head.The study doctors were unable to relieve the pain.I was not informed of this risk.Rather, i was told this pain never happens.I was even told that i was imagining the pain.Months later, i learned that nerves may been damaged by the leads.The extreme pain greatly impaired my movement and caused atrophy of my right side.Performing my daily life activities was greatly impaired.My depression worsened as a result and i had more suicidal thoughts.After suffering like this for over 6 months without relief, the study doctor referred me to the (b)(6) clinic on (b)(6) 2013.My condition was diagnosed as "lesser occipital neuralgia caused by the dbs generator lead crossing the mastoid notch resulting in a palsy of the lesser occipital nerve." and that "there was also a spinal accessory nerve palsy caused by the same lead crossing distally over the accessory nerve just posterior to the sternocleidomastoid," resulting in "significant atrophy of the trapezius." the study doctor was unable to relieve the chronic and disabling pain i suffered from the dbs clinical trial.The study doctor believed that surgical removal of the dbs device was necessary to prevent the pain and disfigurement from worsening.On (b)(6 )2013 the study doctor removed the dbs system but the study doctor was wrong.The pain, disabling impairment, and physical disfigurement continue.After the dbs device was removed, the study staff has left me to seek treatment for myself at tremendous cost.

• Type of Device: LIBRAXP NON-RECHARGEABLE IPG
• Manufacturer (Section D): ADVANCED NEUROMODULATION SYSTEMS, DBA ST.JUDE MEDICAL NEUROMODULATION DIVISION,
• MDR Report Key: 5364668
• MDR Text Key: 35929351
• Report Number: MW5059285
• Device Sequence Number: 1
• Product Code: LGW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 73