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

Model Number 37612

Device Problem Failure to Deliver Energy (1211)

Patient Problem Fatigue (1849)

Event Date 03/16/2024

Event Type  malfunction  

Event Description

Information was received from a patient regarding an external device.The patient reported that the wireless recharger (wr) was not making the beeping tones to indicate the implanted neurostimulator (ins) was fully charged.As a result, the ins turned off and made the patient exhausted to the point that their son had to come help them.The patient reported this issue to their managing healthcare provider (hcp) and manufacturer representative (rep), but no troubleshooting was completed because the patient said neither their hcp nor the rep had any experience with the wr.The patient mentioned that they charged the ins for an hour or two, but they still did not hear the wr make the beeping tones to indicate the ins was fully charged.Agent had the patient use the wr during the call and agent heard the wr make a connection to the ins initially, but the patient powered off the wr shortly after it made the connection.Agent advised the patient to power the wr back on, but they powered it off again shortly after the wr connected to the ins.Agent had the patient power the wr back on and it connected to the ins again.Agent reviewed that the wr needs to remain powered on in order to charge the ins.The patient understood.Agent then had the patient check the status of their ins with the 37642 patient programmer, which indicated that therapy was turned on and the ins was charged to 100%.Agent reviewed that the patient programmer updates the ins charge level in quartiles, and advised the patient to charge the ins for at least an hour and monitor the wr to ensure it makes the beeping tones to indicate a fully charged ins.The patient said they would do as advised.Agent advised the patient to call back if they have further concerns.

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.Continuation of d10: product id wr9200 (serial: (b)(6)); product type: 0213-recharger; 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: 18954101
• MDR Text Key: 338554361
• Report Number: 3004209178-2024-07563
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Date Device Manufactured: 03/28/2017
• 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: 74 YR
• Patient Sex: Female