• 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 STIMUATOR

  • 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 STIMUATOR Back to Search Results
Model Number SC-1110-02
Device Problems Device Inoperable (1663); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 05/03/2018
Event Type  malfunction  
Event Description
A report was received that the patient will undergo a revision procedure for an unknown reason.
 
Manufacturer Narrative
Additional information was received that date rec¿d by mfr of the initial mdr is 02may2018. The patient underwent an ipg replacement procedure due to a non-functional ipg. No device malfunction was suspected. The patient was doing well postoperatively. The explanted device was not returned to bsn.
 
Event Description
A report was received that the patient will undergo a revision procedure for an unknown reason.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRECISION
Type of DeviceSPINAL CORD STIMUATOR
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 Key7546184
MDR Text Key109311992
Report Number3006630150-2018-01852
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,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/06/2016
Device Model NumberSC-1110-02
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 Received05/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2014
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: 05/25/2018 Patient Sequence Number: 1
-
-