MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number	37602
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 3387-40 lot# l83936 serial# implanted: (b)(6) 2000 explanted: product type lead product id 3387-40 lot# l71688 serial# implanted: (b)(6) 1999 explanted: product type lead product id 37602 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: product type implantable neurostimulator product id 37602 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: product type implantable neurostimulator section d information references the main component of the system.Other relevant device(s) are: product id: 3387-40, serial/lot #: l83936, ubd: 11-aug-2004, udi#: (b)(4); product id: 3387-40, serial/lot #: l71688, ubd: 11-oct-2003, udi#: (b)(4) 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 during replacement of the implantable neurostimulator (ins)- due to normal battery depletion - an out of range (oor) impedance was detected on contact 3 of the lead.Values were measured at 162 monopolar contact 3 l stn.The impedance on this contact was within range upon first connecting the battery but resulted in an oor value after a second check.Patient records noted a history of intermittent impedances on this contact.Patient was not currently receiving therapy on this contact.No further action was planned at this time.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 23712359
• Report Number: 3004209178-2025-20484
• Device Sequence Number: 8910142
• Product Code: PJS
• UDI-Device Identifier: 00763000519223
• UDI-Public: (01)00763000519223(17)260614
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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: 06/14/2026
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/03/2025
• Date Device Manufactured: 12/26/2024
• 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...."
• Patient Age: 85 YR
• Patient Sex: Female