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

Model Number 37601

Device Problems Device Difficult to Program or Calibrate (1496); Low impedance (2285)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 02/25/2015

Event Type  Injury  

Event Description

It was reported the parkinson¿s disease patient experienced ¿less than 50% therapy relief¿ in their ¿left hemibody¿ at the time of report.¿immediately after implantation¿ impedance testing was performed and ¿showed a short on two contacts.¿ the impedance testing records indicated bipolar electrode pair 1 and 2 had a low impedance value of 32 ohms (also reported as 52 ohms).It was noted that no impedance measurements had been taken during implant.Reprogramming the patient was reportedly ¿difficult,¿ but the patient ¿was receiving therapy¿ as of 19 days after initial report.A date to revise the patient¿s system was not yet planned; but a revision was expected as the patient¿s ¿neurologist was convinced [the patient] would be better with an intact system.¿ additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant: product id 3708660, implanted: 2015-(b)(6), product type extension.Product id 3389-40, lot# unknown, implanted: 2015-(b)(6), product type lead.(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: 4628331
• MDR Text Key: 18544289
• Report Number: 9614453-2015-00547
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Other
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2015
• Date Device Manufactured: 01/05/2015
• 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