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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 Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 05/07/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id 97755 lot# serial# (b)(4) implanted: explanted: product type recharger. Information references the main component of the system. Other relevant device(s) are: product id: 97755, serial/lot #: nlf040437n, ubd: , udi#: (b)(4). Is year valid. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for rsd/causalgia-complex regional pain syn and non-malignant pain. It was reported that the pt has 2 inss. Pt called about the ins on the right side implanted for her legs (97715). The ins on the left side was for her hands. The pt reported that her ins battery gets really hot and burns her when charging in the last month or so when she has the paddle piece over it. It starts charging ok and all of a sudden it turns red and burns her skin. The ins battery itself burns from the recharging paddle piece. Pt got to the point where she could not take it. Recharger looks ok, it is not damaged. Pt said she did not get any burning marks on the skin. Pt mentioned she was scheduled to see the rep on (b)(6) at her rsd healthcare provider. Pt also thought she had one ins that would last 4 years and the other one 9 years. Reviewed the longevity/eri/eos of both inss. Pt then was hard to understand, did not catch whether she said 'paying for surgeries' or 'painful' surgery.
 
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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 Key11968339
MDR Text Key267121087
Report Number3004209178-2021-09101
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 09/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2019
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 Received09/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2018
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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