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

Model Number 7428

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013); Skin Erosion (2075)

Event Type  Injury  

Manufacturer Narrative

Product id: 7482-51, serial# (b)(4), product type: extension.Product id: 7482-51, serial# (b)(4), product type: extension.(b)(4).

Event Description

The health care provider (hcp) reported via the company representative (rep) that the implantable neurostimulator (ins) and extensions were migrating through the patient's skin wall.The migration has been so great that the corner where the extensions go into the header block were visible on the outside of the patient.There was some infection at the site where the skin was broken.The patient was extremely thin, which led to this event.This has happened before to the patient and it was thought there has been a long standing infection.Pre and post op impedance tests were performed.The surgeon resected the infected skin and implanted the ins deeper under the small amount of remaining breast tissue.The infection required long term antibiotics, surgical wound.The issue was resolved at the time of the report.The hcp has no further information for the device manufacturer.The relevant medical history included parkinson's disease and low body weight.If additional information is received, a follow up report will be sent.

• 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: 5027730
• MDR Text Key: 23943763
• Report Number: 9614453-2015-02148
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2010
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2015
• Date Device Manufactured: 05/27/2009
• 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: 00065 YR
• Patient Weight: 40