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

Model Number 37612

Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Battery Problem (2885); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem Shaking/Tremors (2515)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 37761 lot# serial# (b)(6) implanted: explanted: product type recharger product id 37651 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 #:(b)(6), ubd: , udi#: ; product id: 37651, serial/lot #:(b)(6), ubd: , udi#: (b)(4) h3: analysis of the recharger (serial #:(b)(6) revealed that the recharger had lost software.Analysis of the desktop charger (serial #: (b)(6) revealed that the connector 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

Information was received from a patient's representative regarding an external device.The caller reported that at 1 o'clock in the morning the patient's tremors came on suddenly.The caller said the patient was "shaking like a leaf." unbeknownst to the caller, the patient's ins battery was discharged.The caller tried to use the recharger to charge the ins battery, but the recharger display was blank and it would not power on.The caller reset the recharger, but it still would not power on.The caller noticed the connection between the desktop charger (dtc) and recharger was loose, and then they noticed the dtc connector pin had broken off and got stuck inside the recharger.The caller was unable to remove the dtc connector pin from the recharger.During the call, the caller used the patient programmer to check the ins battery, and they saw the 'recharger battery is in a discharged state' warning screen.Age nt reviewed that the ins battery will need to be charged to at least 25% before therapy can be turned back on.The issue was not resolved.An email was sent to the repair department to replace the recharger and dtc.

• 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: 18971233
• MDR Text Key: 338684911
• Report Number: 3004209178-2024-07756
• 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: Consumer
• Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2015
• 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: 81 YR
• Patient Sex: Male