BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1132656 · Received August 22, 2008

    Report

    Report Number
    2029203-2008-00548
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED OF THE PATIENT RECEIVING A BURN FROM THE CHARGER AT THE IMPLANT SITE. THE SURGEON EXPLANTED THE PATIENT'S PRECISION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-5312 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MODEL # SC-2138-70| LINEAR LEAD (PHASE IIIA)| LINEAR LEAD (PHASE IIIA)| DESCRIPTION: IMPLANTABLE PULSE GENERATOR| MODEL # SC-1110| MODEL # SC-2138-70