MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED

Model Number	37612
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Use of Device Problem (1670); Delayed Charge Time (2586)
Health Effect - Clinical Code	Weight Changes (2607)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: wr9200, lot#serial#: (b)(6), product type: recharger, product id: a620, lot#serial#: unknown, product type: software.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 or Problem Description
It was reported that the patient called regarding a recharger.They encountered an error code 680 while attempting to connect to the dbs therapy app for setting adjustments prior to charging the implant.The patient support specialist (pss) instructed the caller to exit the dbs therapy app and open the recharger application.The patient successfully connected to the recharger app and began a charging session with a good connection.The caller noted that the ins was at 50%, and mentioned that despite charging for an hour, the ins had remained at 25%.The pss reviewed normal charging duration times with the caller.The patient stated that they do not use the drape while charging, as it never worked for them, and expressed concern about whether their significant weight loss might affect the connection between the wr and ins, or if the ins had moved.The caller confirmed that they could maintain a good charging connection.The issue was resolved through troubleshooting.The caller noted they had previously replaced the recharger.The patient called back to report that they've continued to have issues with the wr.Patient repeated that they had issues with the wr connecting to the ins, noting that the wr would lose connection if they moved a quarter of an inch.The patient mentioned that they had surgery in august of last year and mentioned that "it moved to the other side" patient did not elaborate on this.The patient stated that they've had their recharging equipment for 5 years and "had problems with every little piece." the patient added that the wr would run out of charge 30-45 minutes into an ins charging session.The patient was not willing to do any troubleshooting.The patient indicated that external equipment had been replaced in the past.The patient stated, "my device is at a 13 - that's a problem.So not that it does a great deal of good because it's not doing fantastic, but i can't flop it to what she needs me to flop it to because we're doing changes right now.And i can't do anything with it sincei don't have enough charge." patient did not elaborate and agent did not ask for clarification due to nature of the call.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 25161811
• Report Number: 3004209178-2026-08205
• Device Sequence Number: 15611979
• Product Code: MBX
• UDI-Device Identifier: 00763000100360
• UDI-Public: (01)00763000100360(17)210414
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/13/2026
• Date Device Manufactured: 05/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female