MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; Deep brain stimulator for obsessive compulsive disorder (OCD)

Model Number	37612
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Pneumonia (2011); Electric Shock (2554); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 has been experiencing a stinging sensation above the implant site, particularly during recharging, which is described as feeling like an electrical shock.This issue has been ongoing for the past couple of years.The patient expressed concern about the possibility of a fracture and noted that the implant has been shifting since approximately 2021, with the skin over the implant appearing very thin.The patient also reported that in (b)(6) 2023, after developing pneumonia and coughing frequently, their ocd symptoms worsened abruptly.The patient mentioned seeing a healthcare provider, who indicated that impedances appeared normal.The patient, lacking a current managing physician, has experienced difficulty finding a new provider due to having received the implant for ocd.Device information was reviewed, and the patient was redirected to their healthcare provider for further evaluation and management of their concerns.

• Brand Name: ACTIVA
• Common Device Name: Deep brain stimulator for obsessive compulsive disorder (OCD)
• 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: 22710873
• Report Number: 3004209178-2025-13180
• Device Sequence Number: 18544720
• Product Code: OLM
• UDI-Device Identifier: 00643169105492
• UDI-Public: (01)00643169105492(17)180114
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: H050003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 08/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2018
• 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: 07/16/2025
• Initial Report FDA Received Date: 08/05/2025
• Date Device Manufactured: 02/16/2017
• 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
• Patient Sex: Female