• 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 ULTRA 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 ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37712
Device Problems Break (1069); Difficult to Remove (1528); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/21/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 3998, lot#: v001559, implanted: (b)(6) 2006,explanted: (b)(6) 2020, product type: lead. Product id: 3998, serial/lot #: (b)(4), ubd: 07-dec-2009, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received via a manufacturer representative from a health care professional regarding a patient who is implanted with a neurostimulator. It was reported that the patient presented for a battery replacement. The surgeon had a difficult time removing the lead from the port of the old implantable neurostimulator, and then could not get it to go into the new battery. Additional contributing factors were unknown. The surgeon attempted to insert the lead into the new implantable neurostimulator port multiple times and tried the bottom port; however, the issue did not resolve. The surgeon ended up replacing the entire system to resolve the issue. There were no further complications reported or anticipated.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESTORE ULTRA
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 Key10309436
MDR Text Key199978731
Report Number3004209178-2020-12635
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,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2011
Device MODEL Number37712
Device Catalogue Number37712
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/14/2011
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: 07/22/2020 Patient Sequence Number: 1
-
-