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

Model Number 7426

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); No Device Output (1435); Device Operates Differently Than Expected (2913)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 03/05/2016

Event Type  Injury  

Manufacturer Narrative

Product id: 7438, serial# (b)(4), product type: programmer, other applicable components are: product id: 7426, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.

Event Description

The patient reported that one of the two implantable neurostimulators (ins) stopped working on the morning of two days prior to the report.The patient successfully turned the ins back on (it was the ins implanted under the right collar bone).In the afternoon the same ins turned off again, and despite the patient was checking the battery status regularly, it was shown okay.The patient tried to switch it on a few times, but it was not possible to turn on the ins again.There was no emi disturbances.The patient was implanted all together for 10 years (including previous devices), very experienced and satisfied with deep brain stimulation (dbs).Because it was not possible to switch the ins back on, his doctor was notified immediately since his clinical picture became worsen.A re-implantation of both inss were already scheduled.The inss will be replaced.It was noted the ins implanted under the left collar bone was still working normally and showing okay, 3.61v.There was no patient harm, injury or death.The company representative (rep) additionally reported that they would like to send the patient programmer (pp) for analysis.When communicating with the clinician programmer on "(b)(6) 2016," the left ins showed a status of ¿battery ??? still working.¿ the last time the patient was examined with the clinician programmer was in (b)(6) 2014, the battery¿s status at that time were: left chest battery 3.71v and right chest battery 3.72v, both hemispheres bipolar settings.Left hemisphere: 0-, 1+, 3.5v, pw 150micros, rate 130hz.Right hemisphere: 1-, 2+, 3.5v, pw 150micros, rate 130hz.Clinical picture worsened was further clarified as dystonia of the left side of the body (contralateral to the impaired ins); torticollis, trunk, leg and art dystonia that was painful too.Troubleshooting was performed, the patient was clinically examined by a movement disorders specialist on (b)(6), one day after the deterioration started.The status of inss were checked too and the right one was non responsive.The patient did not report any falls or trauma.Both inss were replaced on (b)(6) 2016.The indication for use included generalized dystonia.

Manufacturer Narrative

Correction: please note that conclusion code no longer applies to this report.Device evaluation: analysis of the implantable neurostimulator (ins) found the ins had reached ¿normal end of life¿ with ¿no telemetry and no output.¿.

Manufacturer Narrative

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): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5538543
• MDR Text Key: 41569078
• Report Number: 9614453-2016-01658
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2012
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2011
• 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): Required Intervention
• Patient Age: 00050 YR