BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2683518 · Received August 6, 2012

    Report

    Report Number
    3006630150-2012-01418
    Event Type
    Injury
    Date Received
    August 6, 2012
    Date of Event
    July 16, 2012
    Report Date
    July 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS DECEASED. THE PHYSICIAN STATES THE DEATH WAS DUE TO NATURAL CAUSES AND WAS NOT RELATED TO THE STIMULATOR.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING DUE TO IPG BEING FLIPPED WHICH WAS CONFIRMED BY X-RAY. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING DUE TO IPG BEING FLIPPED WHICH WAS CONFIRMED BY X-RAY. THE PATIENT WILL UNDERGO A 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention