BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1960883 · Received January 12, 2011

    Report

    Report Number
    3006630150-2011-00020
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT IS EXPERIENCING OCCASIONAL MUSCLE SPASMS IN HER BACK PRIMARILY WHEN THE DEVICE IS ON AND THE MUSCLE SPASMS WOULD GO AWAY WHEN THE DEVICE IS TURNED OFF. THE PHYSICIAN IS TREATING THE PT WITH MUSCLE RELAXERS AND ADVISED THAT THERE WOULD BE NO COURSE OF ACTION OTHER THAN THE MEDICATED TREATMENT AT THIS TIME.

    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 54 YR Required Intervention ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014" STYLET| (B)(4)| MODEL # SC-2218-70, SERIAL # (B)(4)