BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERIPRECISION

    MDR report key: 1151345 · Received September 4, 2008

    Report

    Report Number
    2029203-2008-00562
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 2, 2008
    Report Date
    August 7, 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
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED MATERIALS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A COMPLAINT OF INFECTION AT THE POCKET SITE WAS REPORTED. THE PATIENT'S SYSTEM WAS EXPLANTED. THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ST LINEAR LEAD| ST LINEAR LEAD