• 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 SPECTRA WAVEWRITER 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 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1160
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812); Hemorrhage/Bleeding (1888)
Event Date 06/01/2021
Event Type  Injury  
Manufacturer Narrative

Date of event: exact date unknown, event occurred in first week of (b)(6) 2021. Additional suspect medical device component involved in the event: product family: scs-paddle leads, upn: m365sc8336700, model: sc-8336-70, serial: (b)(4), batch: 7036351.

 
Event Description

It was reported that the patient had infection at the ipg site which was not resolved with antibiotics. The patient noticed that the ipg wound site was opening and the patient experienced bleeding puss at the ipg site. The physician believed that the infection was procedure related and was not device related. All device components were explanted and were not returned.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSPECTRA WAVEWRITER
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
cashel road
clonmel
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12260061
MDR Text Key264529349
Report Number3006630150-2021-04250
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 08/02/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/02/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberSC-1160
Device Catalogue NumberSC-1160
Device LOT Number374963
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 Received07/14/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/21/2020
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: 08/02/2021 Patient Sequence Number: 1
-
-