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

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION 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
 

BOSTON SCIENTIFIC NEUROMODULATION PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1110-02
Device Problems Unexpected Therapeutic Results (1631); Defective Device (2588)
Patient Problems Irritation (1941); Pain (1994); No Code Available (3191)
Event Date 06/08/2012
Event Type  Injury  
Manufacturer Narrative

Exact date unknown, event occurred several months ago from the aware date. Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2352-70, serial: (b)(4), batch: 14587146/14637797.

 
Event Description

It was reported that the patients pocket site was easily irritated. Pain at the ipg site and left buttock area were also reported. It was also noted that the ipg was non-functional and patient had inadequate stimulation. All components were explanted and discarded. The patient was doing well postoperatively.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRECISION
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key10849167
MDR Text Key216568249
Report Number3006630150-2020-05572
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP030017
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 11/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/01/2014
Device MODEL NumberSC-1110-02
Device Catalogue NumberSC-1110-02
Device LOT Number15020611
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 Received10/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/28/2012
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: 11/16/2020 Patient Sequence Number: 1
-
-