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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 Overheating of Device (1437); Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 03/01/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger. Product id: 97755, serial/lot #: (b)(4), ubd: , udi#: (b)(4). Date of event: date is approximate. 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. It was reported that the patient (pt) stated he was having problems with the "apparatus" as he can't recharge the ins as everything "is kind of haywire". Patient service's (pss) asked the pt if he receives error messages on the controller while trying to recharge the ins and the pt stated that he does on and off; pss asked the pt what error messages appear on the controller when try to recharge the ins and the pt stated that he doesn't know as they don't mean anything to him, so he doesn't pay much attention to it and that all he knows is that now its become a situation where the handheld is starting to get warm and almost hot. The pt stated that this was unusual as he didn't thin that it had much of a battery in it; pss attempted to clarify further with the pt and the pt confirmed that the recharger (rtm) is getting extremely hot. The pt stated that he's getting burned from where the rtm cable goes into the p addle; pss asked the pt if it's leaving burning mark's on his skin and the pt stated yes and that this happened before when he troubles last time (pt stated this was about a year ago) - pss was unable to locate  a case where this information was previously reported. The pt noted that the ins battery was at 40%, so as long as he tries to keep the ins off he'll be okay; pss was understanding that the pt was trying to make the ins battery last until the replacement rtm is received so then he can recharge his ins. The pt stated that this happened probably a month to six weeks ago.
 
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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 Key11568251
MDR Text Key242227767
Report Number3004209178-2021-04900
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
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2019
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 Received06/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2018
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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