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

Model Number 37612

Device Problems Overheating of Device (1437); Low impedance (2285)

Patient Problem Burning Sensation (2146)

Event Date 04/08/2024

Event Type  malfunction  

Manufacturer Narrative

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 the patient was implanted on (b)(6) 2024 with a rechargeable implantable neurostimulator (ins) and the patient reports a sensation of warmth during recharging session when the ins is on.This is resolved when the device is turned off during recharging.The speed of recharging was lowered from 3 to 2.The patient felt normal for 30 minutes of recharging. as the surgery happened on (b)(6) 2024, the implant site may not fully healed.No sign of infection detected in the latest visit.The patient charges using the recharging drape.When the recharge speed was reduced from 3 (warmest) to 2, the patient felt better, with no burning at the implant site.The recharge speed was changed on (b)(6) 2024. the burning sensation is only present during the recharge session with stimulation on.The system has not been palpated.Impedance measurement showed that electrode 9-10 is short-circuited (bipolar 9-10 is ~50). the surgeon was notified and they assumed that the impedance will be normal after one month.Impedance is measured at every visit.The patient is receiving sufficient therapy.

Manufacturer Narrative

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

Additional information was received from the manufacturer representative (rep) that it is unknown if the impedance issue was present on the day of the implant surgery.The cause of the impedance issue was not determined.No actions were taken.The surgeons decided to monitor the impedance for at least one month.

• 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: 19104361
• MDR Text Key: 340136803
• Report Number: 2182207-2024-02297
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2024
• 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: 54 YR