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

Model Number 37612

Device Problems Failure to Power Up (1476); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 37761 lot# serial# (b)(6) implanted: explanted: product type recharger product id 37751 lot# serial# (b)(6) implanted: explanted: product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 37761, serial/lot #: c0638032, ubd: , udi#: ; product id: 37751, serial/lot #: (b)(6), ubd: , udi#: h3: analysis of the recharger (serial #: (b)(6)) revealed that the software was lost.Analysis of the desktop charger (serial #: (b)(6)) determined the pin was broken off.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

It was reported that the patient had an activa rc that was placed (b)(6) 2018 and they are unable to charge the stimulator as the external parts of the system suddenly stopped working.The patient controller was working fine per the patient and their implant showed 75%.They reported they hope the issue resolves before they "run out of juice".The power adapter was getting electricity and it's led turns on.The cord from the power brick to the recharger felt loose when plugged into the recharger and the arrows were aligned.The wires were visible where they meet the molded plastic plug, the outer insulation dislodged from the molded plug "some time ago".The recharger will not turn on regardless of what button they push and it may be dead.The patientsuspected the cord from the power adapter to the recharger has failed and that the external battery had now been run dry and lost it's recharge capacity.The patie nt did notice progressively longer recharging times, and noted it was maybe due to the recharger battery not recharging and ultimately leading to total failure of the external charging system.The patient requested replacement of all components of the charging system by overnight express as they were not sure how long their implant would function without completely running out of charge and permanently reducing its capacity and lead to premature replacement of the implant which they want to avoid.The patient asked if the cable breaking was the root cause if it would be possible for them to have a newer cordless system rather than sending the same system since in their experience it has demonstrated 100% chance of failure, as this would be the second time they had this problem.Patient noted they will call in the morning due to the urgency of their request.Pss emailed patient tocall into ps.Information was received from a consumer who reported the desktop charger cord pulled away from the connector, so the wires were exposed.The desktop charger continued to charge the recharger when they noticed the issue with the cord, but after the last week the recharger seemed to eb taking longer to charge, and yesterday the recharger stopped taking a charge at all as the ¿charge your recharger¿ screen was seen even though the desktop charger was attached.It was confirmed the connection between the desktop charger and recharger was loose and one of the contact pins inside of the recharger connector port appeared bent.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 18975328
• MDR Text Key: 339108019
• Report Number: 3004209178-2024-07771
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• 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
• Treatment: "SEE H11...."