MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Failure to Power Up (1476); Delayed Charge Time (2586); Battery Problem (2885); Connection Problem (2900); Material Integrity Problem (2978)

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

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 37751 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).H3: analysis of the recharger (serial #: (b)(6) revealed that the recharge board was bad.Analysis of the desktop charger (serial #: (b)(6) revealed the connector pin was broken.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 information was received from a manufacturer's representative (rep) via a patient regarding an external device.The reason for call was the patient reported that they charged to 50% yesterday and then attempted to charge later in the day and the recharger would not power on.The patient reported that the patient let the battery deplete completely and the therapy turned off, so that is why they charged the ins yesterday.The patient indicated that they charge the ins every couple of days and at the time of the call the battery status was showing low.The patient also reported that they noticed that the dtc cable was making a loose connection with the insr.Tss had the caller confirm that the dtc light was on and the insr was plugged in.The caller pressed the green button on the recharger and the screen did not turn on.The issue was not resolved through troubleshooting.Technical services sent request to repair to replace the insr and dtc.No symptoms were reported.Additional information received from the manufacturer¿s representative (rep) reported the patient¿s battery depleted so they gave them a wireless recharger.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18972969
• MDR Text Key: 338594001
• Report Number: 2182207-2024-02107
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• 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: Company Representative
• 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: 08/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2013
• 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...."
• Patient Age: 75 YR
• Patient Sex: Male