BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1934355 · Received November 24, 2010

    Report

    Report Number
    3006630150-2010-01929
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS EXPERIENCING A SHOCKING SENSATION AROUND HIS FEET, HANDS, AND ACROSS THE CHEST WHEN HE WALKED AROUND WITH THE STIMULATION ON. X-RAY CONFIRMED A KINK IN THE LEAD. THE PT WAS REPROGRAMMED AND CONFIRMED THAT HE WAS RECEIVING PAIN RELIEF FROM THE NEW PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR ST LINER LEAD, 50CM WITH PRE-LOADED 0.014" STYLET:| SERIAL#: (B)(4)| IPG KIT (WITHOUT PULL-THROUGH TUNNELER):| SERIAL#: (B)(4)| MODEL#: SC-1110-02| MODEL#: SC-2218-50