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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPINAL CORD STIMULATOR

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1110-02
Device Problems Device Inoperable (1663); Charging Problem (2892)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2016
Event Type  Malfunction  
Manufacturer Narrative

The explanted ipg was not returned to bsn as it was kept by the medical facility. A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

 
Event Description

A report was received that the patients ipg was non-functional and it was taking longer to charge. The patient underwent an ipg replacement procedure and was doing well postoperatively.

 
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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 Key7155334
MDR Text Key96066235
Report Number3006630150-2017-05340
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN Number030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation PATIENT
Type of Report Initial
Report Date 12/29/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/01/2014
Device MODEL NumberSC-1110-02
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/28/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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