BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3160483 · Received June 10, 2013

    Report

    Report Number
    3006630150-2013-01183
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT IPG REPLACEMENT AND WAS DOING WELL FOLLOWING THE PROCEDURE. THE COMPLAINT WAS CONFIRMED. THE IPG EXHIBITS PREMATURE BATTERY DEPLETION. BATTERY DEPLETION AND SLEEP CURRENT RATES OF THE DEVICE WERE EXCEEDING THE EXPECTED RANGES, 23.49 MV PER DAY AND 342 UA RESPECTIVELY. TROUBLESHOOTING TO SPECIFIC COMPONENT LEVEL WAS IMPOSSIBLE SINCE BOTH ANALOG/DIGITAL ICS ARE COVERED IN THE EPOXY RESIN TOP. THE SOURCE OF THE DEVICE DAMAGE IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS NOT HOLDING A CHARGE. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS NOT HOLDING A CHARGE. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260803 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR