BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1892285 · Received November 2, 2010

    Report

    Report Number
    3006630150-2010-01806
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    July 1, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS DAMAGED BY AN AED (AUTOMATED EXTERNAL DEFIBRILLATOR) DURING A NON-DEVICE RELATED PROCEDURE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINA CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention