• 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 MONTAGE MRI 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 MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 10/03/2018
Event Type  Injury  
Manufacturer Narrative

The explanted device was not returned to bsn. It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. A review of the device history records will be conducted. If there is any further relevant information from that review, a supplemental med watch will be filed.

 
Event Description

A report was received that the patients implant was causing lupus and attacked her spine. The patient underwent an explant procedure.

 
Event Description

A report was received that the patients implant was causing lupus and attacked her spine. The patient underwent an explant procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRECISION MONTAGE MRI
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 CLONMEL LIMITED
cashel road
,
clonmel
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key8007416
MDR Text Key125091221
Report Number3006630150-2018-61528
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,Followup
Report Date 11/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/18/2020
Device MODEL NumberSC-1200
Device Catalogue NumberSC-1200
Device LOT Number356047
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 Received10/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/19/2018
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: 10/25/2018 Patient Sequence Number: 1
-
-