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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problem Overheating of Device (1437)
Patient Problems Burn(s) (1757); Burning Sensation (2146)
Event Date 11/28/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 37791, serial#: unknown, product type: recharger. Product id: 37751, serial#: (b)(4), product type: recharger. Other relevant device(s) are: product id: 37791, serial/lot #: unknown. Product id: 37751, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient. It was reported that their recharger started to heat up. The patient stated that the recharger antenna got hot and burned their skin. The patient mentioned that at first, they thought their skin was just getting warm but then noticed that it was burned. It was noted that the patient thought the issue first occurred on (b)(6) 2020. The repair department was contacted and a replacement recharger was requested. No further complications were reported or anticipated. Indication for use is spinal pain.
 
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Brand NameSURESCAN
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 Key10998458
MDR Text Key221254141
Report Number3004209178-2020-21733
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,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2016
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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