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

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG SYNERGY 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
 

MDT SOFAMOR DANEK PUERTO RICO MFG SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 7427
Device Problems Low Battery (2584); Battery Problem (2885); Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Information was received from a healthcare facility and a manufacturer's representative regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that the patient had a history of low back pain which radiated into both extremities. The ins wasn't working/failed and it was evaluated and noted to have reached its end of life. The patient had the stimulator removed/replaced on (b)(6) 2013. No further complications reported.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event. If information is provided in the future, a supplemental report will be issued.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNERGY
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7663799
MDR Text Key113192232
Report Number1030489-2018-00966
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
Report Date 10/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/28/2003
Device MODEL Number7427
Device Catalogue Number7427
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 Received08/08/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/12/2002
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: 07/05/2018 Patient Sequence Number: 1
-
-