• 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 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 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37711
Device Problems Break (1069); Degraded (1153); Connection Problem (2900); Device Contamination with Chemical or Other Material (2944); Impedance Problem (2950)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead. Product id: 3778-60, serial/lot #: (b)(4), ubd: 23-sep-2015, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient was having the implantable neurostimulator replaced due to normal eos.  there was difficulty removing the lead from the implantable neurostimulator. A little corrosion was noted on the end after they got it out. Difficulty putting lead into the new implantable neurostimulator. There were known impedance issues on contacts 6 and 7 from interrogating the implantable neurostimulator prior to the procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESTORE
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11302419
MDR Text Key232401865
Report Number3004209178-2021-02252
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,Followup,Followup
Report Date 02/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2012
Device MODEL Number37711
Device Catalogue Number37711
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/28/2011
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: 02/09/2021 Patient Sequence Number: 1
-
-