• 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 SPECTRA 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 SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1132
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Event Date 06/25/2021
Event Type  Injury  
Event Description

It was reported that the patient was admitted to the hospital a few weeks after the spinal cord stimulation implant procedure for a potential infection at the site of her implantable pulse generator ipg as there was noted swelling and a fever. The patient also was diagnosed and treated for blood clots. A diagnosis of infection at the site of the ipg was inconclusive, however, iv antibiotics were administered as a precaution. Following treatment, the patient was discharged from the hospital and was cleared of all infection and blood clots.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRECISION SPECTRA
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 Key12304814
MDR Text Key265974508
Report Number3006630150-2021-04429
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberP030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/22/2019
Device MODEL NumberSC-1132
Device Catalogue NumberSC-1132
Device LOT Number202233
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 Received08/16/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/22/2017
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: 08/10/2021 Patient Sequence Number: 1
-
-