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

Model Number 37601

Device Problems Premature Discharge of Battery (1057); Impedance Problem (2950)

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

Event Type  Injury  

Event Description

It was reported that on (b)(4) 2014, the implantable neurostimulator (ins) reached elective replacement indicator (eri).The reporter stated that premature battery life was suspected.It was noted there was an eri notification for six days.It was further noted that impedance testing and reprogramming was done.The reporter stated the ins was replaced on (b)(6) 2014.It was noted the patient was programmed with the following settings ¿1-, 9-/ p 330 and r 150.¿ it was noted that there were no patient symptoms or complications associated with this event.It was further noted the patient status at the time of this report was alive with no injury.Additional information received reported the ins was explanted on (b)(6) 2014.The reporter stated that no longevity calculation was done.It was further noted that some electrodes on the right hemisphere were out of range.It was noted that c and 11 had an impedance of 2456 ohms.Additional information was requested, but was not available as of the date of this report.

Manufacturer Narrative

(b)(4).

• Brand Name: ACTIVA
• 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: 3960852
• MDR Text Key: 4605386
• Report Number: 9614453-2014-01555
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2014
• Date Device Manufactured: 11/14/2013
• 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