• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97714
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2021, product type: lead. Product id: 3550-29, lot#: unknown, product type: accessory. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a manufacturer representative, regarding a patient implanted with a neurostimulator (ins). The device was replaced for normal battery depletion. It was reported that battery potentially burned patient. Patient skin inside pocket appeared to be burned /charred.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
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 Key12318349
MDR Text Key266393771
Report Number3004209178-2021-12362
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
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 Received08/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/14/2014
Device MODEL Number97714
Device Catalogue Number97714
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/10/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/16/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-