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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Failure to Power Up (1476); Battery Problem (2885); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

It was reported that it was noticed the desktop charger (dtc) connector pin was broken.As a result, the patient could not charge the recharger and, therefore, could not charge the implant.The patient's wife mentioned that the recharger indicated the patient's implant charge level was getting low.The patient's wife was worried the implant might run out of charge.The agent reviewed that the dbs therapy will turn off if the implant battery discharges.If that happens, the agent reviewed that the implant must be charged before the therapy can be turned back on with the patient programmer.The patient's wife understood.The patient's wife also mentioned that the patient recently installed a replacement recharger antenna, and they think the desktop charger connector pin broke off when they were installing the recharger antenna.An email was sent to the repair desktop charger.Additional information was received from the patient representative in regards to the patients 37751 recharger.The caller stated when the patient received the recharg er antenna and was replacing it the battery pack of the recharger broke.The patient stated that they received the new desktop charger (dtc) and they are still not able to make contact with the recharger.The caller states that there is a piece broken inside the c harging port and they attempted to remove with plyers but were unsuccessful , and still cannot make a connection between the dtc and recharger.The caller stated that the charging port of the 37751 recharger is damaged , and that the 37751 will not turn on.The caller stated that due to these issues the patient has not been able to charge their implantable neurostimulator (ins) and their therapy is currently turned off.The caller states that she thinks the last time the patient charged their ins was about a week to a week and a half.The caller stated that they did contact the healthcare provider (hcp) prior to calling patient services (pss) and the hcp redirected the caller to the manufacturer for further assistance.The caller states that they are not happy with the patients current managing physician, and would like to have transparency on who the local manufacturer's representatives are.Pss advised that if they experience anymore issues with the 37751 charging equipment that they contact their hcp in regards to transition to a wireless recharger.Pss sent an email to repair to replace the dtc and 37751 recharger.Pss sent an email to the caller with physician list ings , and pss sent an email to the local manufacturer's representative to help provide assistance.

Manufacturer Narrative

Continuation of d10: product id 37751 , serial# (b)(6), product type recharger.Product id 37761 lot# serial# (b)(6), product type recharger.Product id 37761 lot# serial# (b)(6), product type recharger.Section d information references the main component of the system.Other relevant device(s) are: product id: 37751, serial/lot #: (b)(6) ; product id: 37761, serial/lot #: (b)(6).Product id: 37761, serial/lot #: (b)(6).Analysis of the desktop charger (b)(6) revealed that the cord was frayed.Analysis of the recharger (b)(6) revealed that the connector was damaged.Analysis of the desktop charger (b)(6) revealed no anomalies with the device.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.

• 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: 18960132
• MDR Text Key: 338371403
• Report Number: 3004209178-2024-07642
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• 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
• Patient Age: 71 YR
• Patient Sex: Male