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

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

  • 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 NEUROMODULATION SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97702
Device Problems Electromagnetic Interference; Failure to Deliver Energy; Device Displays Incorrect Message; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Event Description

The patient reported a neurostimulation failure that occurred after airport staff came close to the battery with a handheld scanner leading to an immediate stop in stimulation and the "contact your doctor" error message. The implantable neurostimulator (ins) turned off due to the security gate. Due to the failure of the stimulation, the patient was unable to walk normally and missed the flight as it was too far to walk to the gate (just barely missed it). The patient suffered mental and physical damage as the battery has only been implanted for three months and now is already run down again by something they brushed off as being normal. The company representative (rep) followed up with the patient's pain clinic where she was being treated. According to the pain clinic this was normal elective replacement indicator (eri) that has occurred quite rapidly as a result of the use of hd stimulation. The clinic suspects the ins failure when the handheld scanner used at the airport was a coincidence. The patient experienced more pain due to the depleted ins. The ins was replaced with a rechargeable ins and the patient status was okay.

 
Manufacturer Narrative

Report source: (b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key5652851
Report Number3007566237-2016-01968
Device Sequence Number1
Product CodeLGW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation Other
Type of Report Initial
Report Date 05/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number97702
Device Catalogue Number97702
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/13/2016 Patient Sequence Number: 1
-
-