BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2853330 · Received November 30, 2012

    Report

    Report Number
    3006630150-2012-02236
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    July 11, 2012
    Report Date
    July 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION, DURING WHICH, THE PHYSICIAN ELECTED TO REPLACE THE IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING HER IPG DUE TO THE LOCATION WHICH IS RIGHT BACKSIDE ABOVE THE WAISTLINE. THE PATIENT HAD TO APPLY A LOT OF PRESSURE TO CHARGE THE IPG. THE PATIENT WILL UNDERGO POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING HER IPG DUE TO THE LOCATION WHICH IS RIGHT BACKSIDE ABOVE THE WAISTLINE. THE PATIENT HAD TO APPLY A LOT OF PRESSURE TO CHARGE THE IPG. THE PATIENT WILL UNDERGO POCKET REVISION.

    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 41 YR Required Intervention