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

Model Number NEU_INS_STIMULATOR

Device Problems Overheating of Device (1437); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Burning Sensation (2146)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The healthcare professional (hcp) reported through a manufacturer representative that the patient experienced issues with both her implant and recharger.The patient observed the following errors on her patient controller: rm03, rm04, ¿trying to recharge¿ with a cross, ¿no device found,¿ ¿no internal device found,¿ ¿system error,¿ ¿! software update,¿ and ¿intellis 3.0 243.Qf_port.¿ no further event information was reported; no complications were reported or anticipated.Additional information was received from the manufacturer representative reporting that the patient was tasered four times in (b)(6) 2020 and the ins has not worked properly since.The ins has not worked since (b)(6) 2020.The patient was laying on the sofa and all of a sudden their skin felt like it was on fire, so they got up and the ins was actually burning them from the inside out.The patient called the device manufacturer right away and was advised to turn everything off.The patient went to the hospital for reprogramming but there was nothing that could be done.The patient received so many error codes.The patient was getting absolutely no relief from their ins.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 12506173
• MDR Text Key: 272480033
• Report Number: 2182207-2021-01622
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2021
• 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