BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1971511 · Received January 21, 2011

    Report

    Report Number
    3006630150-2011-00067
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT ANALYSIS INDICATED THE COMPLAINT OF DIFFICULTY CHARGING THE IPG WAS NOT VERIFIED. UPON RECEIVING, THE IPG WAS DEPLETED COMPLETELY, AND IT WAS CHARGED UP TO THE PROPER VOLTAGE IN ONE CYCLE WITHOUT ANY DISCREPANCIES. THE BATTERY CHARGE PROFILE INDICATES THAT CHARGE ATTEMPTS TO BE FREQUENTLY INTERRUPTED BY THE ASSOCIATED CHARGER, WHICH ARE THE CHARACTERISTICS OF A POOR AIR VENTILATION AROUND THE PATIENT'S CHARGER.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE FOR LEAD MIGRATION, THE PHYSICIAN DECIDED TO REPLACE THE IPG AS THE PT COMPLAINED OF NOT BEING ABLE TO CHARGE. THE PT WAS REPORTEDLY DOING FINE AFTER THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE FOR LEAD MIGRATION THE PHYSICIAN DECIDED TO REPLACE THE IPG AS THE PATIENT COMPLAINED OF NOT BEING ABLE TO CHARGE. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE REVISION PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention