• 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 97713
Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Charging Problem (2892); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that the patient's ins didn't seem to be working. Caller reported that patient had a spinal injection procedure with contrast last thursday, and since then, the implant hasn't been working like it's supposed to. Caller stated the patient had to lay flat for the procedure and turned the stimulation off. Caller said after the procedure, the patient turned the stimulation on, but didn't feel anything. Caller stated that the patient waited a little while and could feel something, but nothing in their legs. Caller said that patient can feel a pulse around the implant site. Caller said that the stimulation comes and goes and that last night, patient couldn't feel it at all. Caller shared that the last time the patient charged their implant was one day last week; caller said the patient usually charges on the 1st and 15th of the month. Caller stated that as the implant has gotten older, the patient has had to charge more frequently, and has been charging twice a month for a couple of years.

 
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 Key12374385
MDR Text Key268460594
Report Number3004209178-2021-12989
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
Report Date 09/29/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2014
Device MODEL Number97713
Device Catalogue Number97713
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/20/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-