• 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 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 SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-2316-50E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 09/25/2017
Event Type  Injury  
Manufacturer Narrative
Sc-2316-50e (sn: (b)(4) device evaluation indicated that the device passed all tests performed.
 
Event Description
A report was received that during the patients trial procedure one of the trial lead was implanted and it was explanted due to medical complications. The physician believed that the medical complication was procedure related and not device related.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: model #: sc-2316-50e serial #: (b)(4) description: infinion 1x16 perc lead and splitter 2x8 kits.
 
Event Description
A report was received that during the patients trial procedure one of the trial lead was implanted and it was explanted due to medical complications. The physician believed that the medical complication was procedure related and not device related.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRECISION
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 Key6949760
MDR Text Key106298276
Report Number3006630150-2017-04101
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729797807
UDI-Public08714729797807
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,Followup
Report Date 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2019
Device Model NumberSC-2316-50E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2017
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: 10/13/2017 Patient Sequence Number: 1
-
-