MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_INS_STIMULATOR

Device Problem Overheating of Device (1437)

Patient Problems Pain (1994); Burning Sensation (2146); Anxiety (2328); Distress (2329)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via a manufacturer representative (rep) regarding the patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient had the software problem screen 99 appear on the patient controller.A photograph of the patient controller displaying this screen was provided and showed diagnostic lines 1 - intellis, 2 - 3.6, 3 - 243, 4 - qf_port.A replacement patient controller and recharger were ordered.A broken recharger was noted.As of the night of (b)(6) 2020, the replacement devices had not been delivered, but the patient took the rechargeable battery out of the controller for about 10 seconds then put it back in the device.The device recharged and was controlling the ins for the patient so for the moment the issue appeared to be resolved; however, it was noted that it could not be said if this was a permanent fix.Additional information was received from the patient.It was noted that the patient noticed that the site over the battery pack was getting very warm after a few times of recharging which they emailed to their consultant who assured the patient that this was normal.The patient discovered the error message while recharging on (b)(6) 2020 again with heat surrounding the implant, and the patient emailed a rep, copying the physician, and asked that it be shown to another rep.A rep advised the patient that they thought it was the recharger that was at fault and that a new one would be sent to the patient.It was noted that a complete unit arrived one week later.The patient reported that they were anxiously waiting for the same message to appear and this pushed their stress levels up.The stress of this had increased the patient's complex regional pain syndrome (crps) pain to flare level.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11041652
• MDR Text Key: 228054079
• Report Number: 2182207-2020-01521
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• 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