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 Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported the battery had premature depletion.The battery was planned to be explanted (b)(6), 2014.It was unknown if there were any patient symptoms or complications associated with the event.Additional information reported the impedance values were within range.The voltage measured was 2.6 volts and the capacity used was 40-85%.It was also noted with the patient¿s settings the device should not be depleted.It was confirmed that the patient had never experienced any kind of ¿shortcut¿ sensation during the study.Additional information reported that it was too early to say if the device was depleting faster than expected.The battery was about half way through the battery and it was possible it would reach its estimated longevity of 8 months.Additional information noted that the battery was now depleted and had a longevity of four months which was less than expected.Additional information noted that the patient was not doing well without their device and was to be explanted in a couple of days.Additional information reported that impedance measurements from the left side showed there was a shortcut between 1 and 3.In chronic stimulation they used left side 0 positive and 1 negative.It was noted this could explain why the battery emptied relatively fast.The battery current drain measured in therapy measurement mode was 200 microamps for both sides.It was noted this was high and part of the explanation on why the battery was emptied in a relatively short period.Due to the patient having had good effect when the stimulator worked, they planned to replace the battery and to investigate the short circuit at a later date.It was noted that due to the condition of the patient there was no time to perform systematic impedance measurements.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported the system was explanted and returned to the manufacturer.

Manufacturer Narrative

Report will be submitted when analysis is complete.

Manufacturer Narrative

The manufacturing site id was previously reported as #3007566237.Additional information indicates the correct manufacturing site id is 9614453.Final analysis of the stimulator revealed no significant anomalies.The stimulator battery was noted as not in the new condition.

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 MN 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: 3748635
• MDR Text Key: 4464196
• Report Number: 3007566237-2014-01013
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: H050003
• 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,Followup
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2014
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2013
• 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