BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1892654 · Received November 3, 2010

    Report

    Report Number
    3006630150-2010-01809
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG WILL NOT BE RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A CAR ACCIDENT, THE PT'S IPG IS NOT RESPONDING. THE PT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND IS DOING WELL. FOLLOWING THE PROCEDURE, THE PT WAS IN A LOT OF PAIN AND THE PHYSICIAN PRESCRIBED THE PT DILAUDID.

    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 78 YR Hospitalization| R