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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); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Burn(s) (1757); Erythema (1840); Burning Sensation (2146); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2021
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id 97755, 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 and consumer regarding a patient with an implantable neurostimulator (ins). It was reported that the patient charged every night. The last two nights the controller showed 'call medtronic' message. They did not know the exact message, she thought it said 'not recharging' or something like that. Last night (2021-03-25) the patient went to charge and the paddle on the recharger got hot and burnt her skin a little bit. Because the patient had muscular dystrophy (unrelated), she had no feeling in her arms and legs, and could not feel her back much. They didn't realize that it was hot. She pulled the recharger out and then noticed that it burnt her skin a little bit, it was really red back there. It was bright red, about the size of a quarter. The recharger was hot enough in her hands for her to feel it. The recharger cord was hot by the donut and the rubber part was really soft. They stated it 'sparked' a little bit and was electrocuting her a little bit. They confirmed her skin now looked fine.

 
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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 Key11599659
MDR Text Key246360542
Report Number3004209178-2021-05291
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/25/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2020
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 Received06/24/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/02/2019
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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