MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37612

Device Problems Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Swelling/ Edema (4577)

Event Date 01/07/2022

Event Type  malfunction  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information was received from a manufacturer¿s representative (rep) who reported the recharger gave a slow pulse as it searched for the implant, but then it would beep like it connected, but disconnected shortly after so they couldn¿t recharge.It was noted the consumer was implanted three days ago so it could be related to swelling so they were going to wait for the swelling to go down before trying again.Additional information received from the manufacturer¿s representative (rep) reported the charging issues were most likely associated with depth.The rep met with the patient today and indicated they were charging in search mode and wanted to compare charge duration of a normal charge with a poor coupling charge.Additional information was received from the manufacturer's representative (rep).The suspected cause of the issue was swelling as patient reports that the swelling has subsided and the patient is able to charge his device with poor coupling.  action/interventions included waiting for the patient's swelling to subside.Additional information was received from the rep reporting the rep was able to confirm that x-rays were taken and show that ins is not flipped.The patient is younger with more muscle tone and some adipose tissue.The patient is still having connection issues with wr and ins where the wr finds the ins and it connects for 30 seconds and then starts beeping.Patient is 4 weeks post-op.The rep's suspicion is recharging issue is related to depth.Rep will work with the patient and surgeon on next steps and additional troubleshooting.Patient services also discussed topics such as depth of ins, flipped ins, optimal starting position of wr over ins, discussed using insr to troubleshoot coupling and al feature.Additional information was received from the rep that patient has been able to find a position where he can better charge.The physician feels that it was a combination of swelling and the implant too deep.They are considering revising the depth but have not committed to doing so as yet.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18980133
• MDR Text Key: 338679463
• Report Number: 3004209178-2024-07848
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00763000519247
• UDI-Public: 00763000519247
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2022
• Date Device Manufactured: 11/15/2021
• 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: 36 YR
• Patient Sex: Male
• Patient Weight: 100 KG