MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA

Model Number 37602

Device Problems Difficult to Remove (1528); Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that this was a normal right battery replacement due to depletion.When the resident pulled the implantable neurostimulator (ins) out, the extension disconnected from the ins without loosening the screws.The manufacturer representative (rep) observed that the incision was not long enough and the resident was struggling to pull the ins out with his fingers.He then used some kind of clamp to secure the ins and forcefully pulled the ins out.He initially pulled and struggled to get it out, then it popped out and the extension disconnected.The rep thinks it is also possible the screws were not tight. .

• Brand Name: ACTIVA
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11738817
• MDR Text Key: 247752606
• Report Number: 2182207-2021-00714
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2021
• Date Device Manufactured: 05/02/2014
• 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 Age: 68 YR