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

Model Number 7428

Device Problems Premature Discharge of Battery (1057); Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2013

Event Type  Injury  

Manufacturer Narrative

Final analysis of the stimulator revealed no significant anomaly.The battery was not in the new condition.

Event Description

It was reported that the battery depletion was normal.It was noted that actions required as a result of the event was surgical intervention.It was noted that the standard surgery procedure to product to replace neurostimulator battery.It was noted that it was unknown if any diagnostic testing or troubleshooting performed.It was noted that the patient status at the time of this report was alive with no injury.Additional information received reported that on the monday prior to explant the therapy impedances were 706 and 944 and current 227 and 171.It was noted that impedance measurements on the left side showed that there was a shortcut between el1 and el3.It was noted that chronic stimulation they use on the left side 0-positive and 1-negative.It was noted that this resulted in chronic stimulation having effectively 2 negative electrodes.It was noted that el1 was intended and el3 was short with el1 which may explain why the battery was emptying relatively fast.It was noted that chronic stimulation they used 6.1 volts, 130 hz, and 210 micros on both sides.It was noted that the battery current drained measured in the therapy measurement mode was for both sides about 200 microa, which was high and this was part of the explanation why the battery was empty in a relatively short period.It was noted that since the patient was receiving good effect when the stimulator worked they decided to implant a new battery despite the fact that there was a short circuit between the electrode contacts on the left side.It was noted that the next step was going to be to find out where the problem was and then try to do it by systematic elaborate non-invasive impedance measurements potentially followed by invasive trouble shooting if evidence of the non-invasive trouble shooting suggested that is what was needed.It was noted that the ¿lifted bond wire issue¿ was not at play in this situation.

Manufacturer Narrative

(b)(4).Analysis results were not available as of the date of this report.A follow up report will be submitted when analysis is complete.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: KINETRA
• 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: 3736853
• MDR Text Key: 11864250
• Report Number: 9614453-2014-00473
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2013
• 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: 00033 YR
• Patient Weight: 84