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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
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.
 
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Brand NameIMPLANTABLE NEUROSTIMULATOR
Type of DeviceSTIMULATOR, 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 Key12506173
MDR Text Key272480033
Report Number2182207-2021-01622
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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