• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • 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 PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97702
Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)
Patient Problems Unspecified Infection (1930); Sepsis (2067); Burning Sensation (2146)
Event Date 09/01/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a legal representative of the patient reporting that immediately after the device was implanted, the patient began to experience burning pain at the battery site. The patient told their doctor about the burning but was advised it was fine. A month later, on november 2, 2015, due to the excruciating burning, the patient presented to emergency room. Emergency surgery was performed to remove the device.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a legal representative of the patient regarding a patient implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that the patient experienced burning at the battery site. A ¿mechanical complication¿ led to infection and sepsis. No further complications were reported or anticipated.
 
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 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7037742
MDR Text Key103218464
Report Number3004209178-2017-23872
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2016
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 Received11/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/09/2015
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: 11/16/2017 Patient Sequence Number: 1
-
-