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

Model Number	37601
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415); Electric Shock (2554); Insufficient Information (4580)
Date of Event	01/01/2023
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 by the patient that they had been having different problems with their brain.The patient said they were walking, dogs started barking, and their head started to hurt and felt like it was getting electrical.They also mentioned their hands were numb.The patient was redirected to their healthcare provider to address the issue further.The patient had not seen a hcp in over a year because the healthcare provider retired.The patient also reported seeing the 'poor communication' screen on their programmer.The patient saw eri (elective replacement interval) on the programmer.Pss reviewed how to bypass the message, and the patient confirmed the stimulation was on.
Event or Problem Description
Patient mentioned they received a cervical epidural steroid injection on (b)(6), but did not elaborate on how this was related.They are hoping to get a battery replacement to resolve their symptoms.
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.

• 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: 20243502
• Report Number: 3004209178-2024-18729
• Device Sequence Number: 7292040
• Product Code: MBX
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: 11/14/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/14/2024
• Date Device Manufactured: 05/18/2018
• 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 Age: 77 YR
• Patient Sex: Female