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); Connection Problem (2900); Material Integrity Problem (2978); Insufficient Information (3190)

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

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 37761 , serial# (b)(6), product type recharger.Product id 37651 , serial# (b)(6), 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).Product id: 37651, serial/lot #: (b)(6) , udi#: (b)(4).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 friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that  the reason for call was caller reported recharger wasn't charging from desk top charger, recharger would show the 'recharge the recharger now' screen even when recharger was plugged into desk top charger.During call the cause of the issue was discovered, caller said that connector pin on desk top charger cord was bent.Inside port of recharger looked fine.A new desktop charger was requested.No symptoms were reported.Additional information was received from the consumer reporting the patient received the desktop charger but recharger is not powering on at all.Caller does not see any damage to the recharger port.An email was sent to repair to replace the recharger.

• 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: 18976043
• MDR Text Key: 338591660
• Report Number: 3004209178-2024-07780
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Date Device Manufactured: 11/26/2014
• 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: 46 YR
• Patient Sex: Female