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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 Material Frayed (1262); Overheating of Device (1437)
Patient Problems Burn(s) (1757); Erythema (1840); Burning Sensation (2146)
Event Date 08/06/2021
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id 97755 lot# serial# (b)(4), product type: recharger. Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4). 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). It was reported that the recharger cord is frayed. Pt stated they felt a burning sensation then last night the cord left a red circle on their skin. They stated the red circle was gone in the morning. The damage was noticed probably about 4-5 days prior. A replacement recharger was requested.

 
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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 Key12316231
MDR Text Key266384054
Report Number3004209178-2021-12344
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 08/12/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/12/2021
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 Received08/11/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/16/2019
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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