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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Energy Output Problem (1431); Overheating of Device (1437); Delayed Charge Time (2586); Charging Problem (2892)
Patient Problems Burn(s) (1757); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Skin Inflammation (2443); Burn, Thermal (2530)
Event Date 02/29/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: unknown: product type: recharger. Other relevant device(s) are: product id: 97755, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins). It was reported that a couple of weeks after implant, group a quit working so they had to switch over to b. The patient texted a rep and said they could feel it on the left side and in some of their left leg. The only places they felt stim was one spot on their back and one spot of their thigh. The patient had to keep turning the power up more and more on a. The rep told the patient he was on hd programming and stim should be set below where the patient feels it. The patient had to crank it back up stating they can feel some of it, but it was not like it was. The patient said after turning to b, they had to charge more. They were charging about 2-3 times per day or every 4-5 hours. Charging difficulty gradually got worse, where before switching to b, the patient would charge the ins to 100% in a half hour. The controller would only be down to 80-90%, but it has gotten to a point where it takes almost 2 hours to charge the ins and it was killing the remote. X-rays were trying to be arranged to ensure the leads didn't move, but this has not been done due to covid-19. It was also mentioned that the recharger was getting hot and felt like it was burning. A picture of blistered skin was sent to the rep. The patient was instructed to turn the charging speed down which the patient said didn't help. It was confirmed the blistering was gone now. The recharger heating seemed to be resolved. It was stated that it got to the point where the patient would charge the ins and it gave them pain in their right hip, "like a pain from pressure while charging. " no further complications were reported.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9961906
MDR Text Key187698477
Report Number3004209178-2020-07197
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 04/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/14/2020
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/17/2019
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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