MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pocket Erosion (2013)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that post operatively the patient's stiffness was improved and the patient could turn over by themselves.However, the left chest stimulator suddenly appeared naked last night, it was clarified the stimulator was suddenly exposed on left chest.Currently, the patient was checked in the hospital.The hcp currently judged there to be two corners of the stimulator battery to be caused by too thick wear.It was unknown how the patient was doing.No further complications were reported.Additional information was received.It was reported the patient had the stimulator explanted on (b)(6) 2019 and had not replaced the new stimulator.

Manufacturer Narrative

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

Event Description

Patient weight was unknown.

Manufacturer Narrative

Analysis of the ins (serial no.(b)(4)) was not performed because the issue was determined to be a non-analyzable medical issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8691077
• MDR Text Key: 147719420
• Report Number: 9614453-2019-01904
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/18/2019; 09/17/2019
• Supplement Dates FDA Received: 06/28/2019; 09/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2017
• 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: 68 YR