• 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 SPINAL CORD STIMULATOR

  • 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 SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994); Thrombosis (2100)
Event Date 03/02/2017
Event Type  Injury  
Event Description
A report was received that the patient was still having pain on the left side and the physician believed that it may be caused by ipg hitting the sciatic nerve. It was also noted that the patient was experiencing thrombotic thrombocytopenic purpura (ttp) at the ipg site. The patient underwent a revision procedure wherein the ipg site was relocated. The patient was doing well postoperatively.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRECISION MONTAGE
Type of DeviceSPINAL CORD STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key6425215
MDR Text Key70600341
Report Number3006630150-2017-00962
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
030017
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 03/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/15/2017
Device Model NumberSC-1200
Device Catalogue NumberNNA
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 Received03/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2016
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: 03/22/2017 Patient Sequence Number: 1
-
-