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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)
Event Date 05/01/2021
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 who was implanted with an implantable neurostimulator (ins) for unknown indications for use. The reason for call was that they had some problems with a rep with setting the therapy to the right area. Pt stated that they had to go to a rep three or four times and that it took three different people until finally someone knew what they were doing and were able to set the therapy to the right spot. Pt stated that the therapy worked great up until about a month ago; pt stated that they started going to physical therapy as they had their hip replaced and that while they were in physical therapy the ins had gone crazy and wasn't working like it used to. Pt stated that it shoots up into their armpits and down their legs (pss understood that the pt was speaking of the therapy) and that when they lay down it turns off (pss understood that the pt was speaking of the ins). Pt stated that therapy uses 50% of the ins battery in two days where it used to be at least three days and close to four days. Pt stated that it's gotten to the point where it's very painful with the ins not working; a couple weeks of not being able to do anything is very difficult for them. It's their low back so just about everything is affected. Pt voiced their dissatisfaction with the availability of reps/customer service.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12023924
MDR Text Key257191733
Report Number3004209178-2021-09594
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 07/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2018
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 Received07/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/09/2017
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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