BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1172082 · Received September 23, 2008

    Report

    Report Number
    2029203-2008-00652
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    October 1, 2005
    Report Date
    August 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORTION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WILL NOT BE EVALUATED, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT OF A PRECISION SYSTEM EXPLANT WAS RECEIVED. THE PATIENT STATED THE SYSTEM WAS NOT PROVIDING RELIEF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LINEAR LEAD 70CM (PHASE II)| LEAD EXTENSION 25CM (PHASE III) MODEL # SC-3138-25| LEAD EXTENSION 25CM (PHASE III) MODEL # SC-3138-25| LINEAR LEAD 70CM (PHASE II)