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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MPRI INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)
Patient Problems Fall (1848); Inflammation (1932); Pain (1994); Dizziness (2194); Discomfort (2330); Electric Shock (2554)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported the recharger was getting very hot and burning when patient is recharging. There was no mention of damage to skin from burning or actual burn to skin. The implant and was very slow to recharge. They stated the ins will charge up to 20-40% and it was a very slow charge, was overheating, and burning. Caller stated it was not what it use to be. The recharger made clicking notices. There was no damage to recharger. The issue was not resolved. The patient was getting shocked around the ins area when recharging and it was delivering a shock around the spine. They could not charge the implant properly because of the shocking. The incision area is inflamed and they wanted to pull out the ins. Caller stated she was not sure if something was wrong with the coil or electrodes not being hooked up. They could only charge for 2 minutes because of the shocking. Patient stated everything was meshed together with the shocking of the ins and/or the recharger paddle. The patient said he had couple falls in the last couple days, one fall happened when they were shocked 4 times in 20 minutes, got really dizzy, fell really hard in the bathtub, and got hurt a day ago. The issue was not resolved.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MPRI
road 149 km 56.3
ceiba norte industrial park
villalba PR 00766
Manufacturer (Section G)
MPRI
road 149 km 56.3
ceiba norte industrial park
villalba PR 00766
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12181860
MDR Text Key261989304
Report Number3004209178-2021-10982
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/10/2021
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/21/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/16/2021 Patient Sequence Number: 1
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