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

Model Number 37612

Device Problems Material Frayed (1262); 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 10/18/2021

Event Type  malfunction  

Event Description

It was reported that the recharger (insr) does not work anymore.Insr won't power on or charge from desktop charger (dtc).The cord leading dtc was frayed, connector pin was bent and the inside of the insr port was damaged.The insr antenna cord was frayed.An email was sent to the repair department to replace the dtc and insr.

Manufacturer Narrative

Continuation of d10: product id 37651, serial# (b)(6).Product type recharger product id 37761, serial# (b)(6).Product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 37651, serial/lot #: (b)(6), udi#: (b)(4); product id: 37761, serial/lot #: (b)(6).H3: analysis of the recharger (serial #:(b)(6)) revealed no anomalies with the device.Analysis of the recharger (serial #: (b)(6)) revealed the connector pin was bent.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.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: 18976047
• MDR Text Key: 338573245
• Report Number: 3004209178-2024-07781
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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: 01/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Date Manufacturer Received: 10/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2019
• 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: 73 YR
• Patient Sex: Male