BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3092890 · Received May 3, 2013

    Report

    Report Number
    3006630150-2013-00913
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL/LOT #: (B)(4)/ 432632, DESCRIPTION: LINEAR ST LEAD WITH PRELOADED ENHANCED STYLET - 70 CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT UNDERGO POCKET AND LEAD REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG EXHIBITED PREMATURE BATTERY DEPLETION BASED ON THE DATABASE ANALYSIS PERFORMED. IT WAS ALSO NOTED THAT THERE WAS A KINK IN THE LEAD. THE PATIENT WILL UNDERGO POCKET AND LEAD REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG EXHIBITED PREMATURE BATTERY DEPLETION BASED ON THE DATABASE ANALYSIS PERFORMED. IT WAS ALSO NOTED THAT THERE WAS A KINK IN THE LEAD. THE PATIENT WILL UNDERGO POCKET AND LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195319 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR