MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37612

Device Problems Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Charging Problem (2892)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient got an activa rc implanted around (b)(6) 2016 and then around the (b)(6) of 2021, they started to notice that they weren't getting good therapeutic benefit from the dbs.The patient said no matter how many different adjustments they had, it didn't seem to improve the therapy.Patient said therefore around the (b)(6) of 2021 (patient said probably (b)(6)), they decided to turn off the therapy and noticed they did better with the dbs off.Patient then kept dbs off and hadn't charged dbs since (b)(6) 2021.The patient tried charging ins yesterday *(b)(6) 2022 and the ins won't charge anymore.The patient said they told their managing hcp about the issue and hcp said device was possibly in overdischarge (od).The patient mentioned this was the first time that there would be possible od.The patient was redirected to their healthcare provider to further address the issue.Hcp wants patient to have device jump started to try to have the patient get reprogramming done to see if therapy could be used again by patient.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14206429
• MDR Text Key: 290084693
• Report Number: 2182207-2022-00694
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 04/26/2022
• 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: 35 YR
• Patient Sex: Male