• 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 CORPORATION 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 CORPORATION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bronchitis (1752); Patient Problem/Medical Problem (2688)
Event Date 01/28/2019
Event Type  Injury  
Event Description

Pt states he was in the hospital twice in the past two months for 5-6 days for bronchitis/flu like symptoms. Pt reports he is feeling well. Pt states he is still undergoing physical therapy and reports amputation he had long before the stimulator was implanted. He is aware fc is working on obtaining replacement remote.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key8301321
MDR Text Key135740729
Report NumberMW5083657
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 01/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/29/2019 Patient Sequence Number: 1
-
-