BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPRECISION

    MDR report key: 1851121 · Received September 30, 2010

    Report

    Report Number
    3006630150-2010-01647
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 28, 2010
    Report Date
    August 30, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO THE IPG PROTRUDING THROUGH THE PATIENT'S SKIN. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention ST LINEAR LEAD 70CM WITH PRE-LOADED 0.014" STYLET| SERIAL # (B)(4)| MODEL # SC-2218-70, SERIAL # A47392