BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1943778 · Received December 21, 2010

    Report

    Report Number
    3006630150-2010-02117
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 2, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A PREVIOUS REVISION, THE PT IS EXPERIENCING RAPID BATTERY DEPLETION. MONOPOLAR ELECTROCAUTERY WAS USED DURING THE PREVIOUS REVISION. THE PHYSICIAN REPLACED THE PATIENT'S IPG AND LEADS. THE PT IS REPORTEDLY DOING WELL.

    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 57 YR Required Intervention SERIAL#: (B)(4)| ST LINEAR LEAD, 50CM 0.014 INCH STYLET PRE-LOADED| MODEL# : SC-2218/50| SERIAL#: (B)(4)