BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1775644 · Received July 21, 2010

    Report

    Report Number
    3006630150-2010-01264
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT EXPERIENCED A JOLTING SENSATION. AFTER TROUBLESHOOTING, THE BSN FIELD CLINICAL ENGINEER (FCE) DETERMINED THAT HIGH IMPEDANCES ARE DUE TO A POSSIBLE BREAK IN THE LEAD THAT COULD BE CAUSING THE JOLTING SENSATIONS. THE BSN FCE WAS ABLE TO REPROGRAM AROUND THE HIGH IMPEDANCES; HOWEVER, THE PT IS INTERESTED IN HAVING THE RIGHT LEAD REPLACED. THE REVISION HAS NOT BEEN SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2208-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.012" STYLET| (B)(4)| MODEL # SC-2208-50