MAUDE Adverse Event Report: IPG MFG SWITZERLAND SOLETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7426

Device Problems Electromagnetic Interference (1194); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Therapeutic Effects, Unexpected (2099)

Event Date 10/12/2014

Event Type  Injury  

Event Description

It was reported that ¿every time¿ the patient¿s hippocampal implantable neurostimulator (ins) was turned on, the patient ¿had seizures.¿ the patient had reportedly been seizure free ¿for a long time,¿ however, the patient¿s seizures had recently ¿come on strong after being exposed to electromagnetic interference¿ (emi).The emi (at a security screener gate) was reported to have turned the patient¿s ins on.This event had occurred on (b)(6) 2014.The ins was turned off following the event.The patient was ¿seizure free for four weeks until (b)(6) 2014 when they had seizures again and fell.¿ as a result, the patient ¿had to go to the hospital for assistance.¿ it was noted that at that time ¿they thought the patient was having a stroke.¿ the patient ¿hadn¿t had another event since (b)(6) 2014 when the hospital reprogrammed the implant to be at 0 volts, so if it came back on accidentally, it would come back on at 0 volts.¿ the patient reportedly experienced ¿anxiety around emi because of the event¿ and ¿wanted the implant removed for peace of mind.¿ additional information has been requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative

Please note, this device was used for an off label indication.(b)(4).

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information reported the patient¿s device was turned off some time laterafter implant because they could not get it to work right.The patient noted their ¿pre-implant seizures worsened¿ with the device and the deep brain stimulation (dbs) ¿made symptoms worse.¿ it was stated that ¿no improvement¿ was received following reprogramming.The ins remained implanted, but off at the time of follow-up.The patient also reported they could not wear a seatbelt over the side of the ins.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOLETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4362757
• MDR Text Key: 21929629
• Report Number: 9614453-2014-03125
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2010
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2016
• Date Device Manufactured: 12/12/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR