• 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 RESTORE SENSOR 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 MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problem Disconnection (1171)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: lead. Product id: 3778-60, serial#: (b)(4), implanted: (b)(6)2012, explanted: (b)(6) 2013, product type: lead. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a consumer concerning patient with an implantable neurostimulator (ins). Patient reported that she had the original ins implanted on (b)(6) 2012 and then on (b)(6) 2013 she had replacement surgery. The patient thinks the replacement surgery was because some of the wires had come unhooked. The patient then stated that it was only one of the wires because the ins was able to be programmed and she could get it to work, but it didn't work quite right, so she was advised to have it redone. The patient states that she doesn't remember the time-frame of when it was discovered that there was an issue with the lead. No further complications were reported/anticipated.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESTORE SENSOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9868632
MDR Text Key184654476
Report Number3004209178-2020-05957
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 03/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/14/2013
Device MODEL Number37714
Device Catalogue Number37714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/22/2012
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: 03/23/2020 Patient Sequence Number: 1
-
-