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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 Overheating of Device (1437); Charging Problem (2892)
Patient Problems Burn(s) (1757); Erythema (1840); Pain (1994); Rash (2033); Burning Sensation (2146); Reaction (2414); Loss of consciousness (2418)
Event Date 03/28/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received by a manufacturer's representative regarding an implantable neurostimulator (ins) for rsd/causalgia complex regional pain syndrome and spinal pain. It was reported that the patient experienced burning at the ins site and were at the emergency room (er). The representative was told that the stimulator was off. The patient later tried to charge the ins as they hadn't used the device since december but when they charged they started to have a reaction on their back and face- the patient had redness in their face, at the ins site, and along the lead system. No further complications reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a representative. It was reported that the patient charged the ins, then went unconscious, and then had burns all over their body. The patient had a rash over the area and burning at the pocket site- the patient continued to have these issues. The ins was currently off and the patient left the ins off as a result of the symptoms that occurred while charging; subsequently, the ins was not treating the pain that they were implanted for. No further complications 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key8470167
MDR Text Key140536482
Report Number3004209178-2019-06406
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 company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2019
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 Received10/12/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/24/2018
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: 04/01/2019 Patient Sequence Number: 1
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