BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1241180 · Received November 20, 2008

    Report

    Report Number
    2029203-2008-00943
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED MATERIALS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT A PT'S PRECISION SYSTEM WAS EXPLANTED, DUE TO AN INFECTION AT THE IPG POCKET SITE. CULTURE RESULTS AND THE TYPE OF ANTIBIOTICS PRESCRIBED TO THE PT WILL NOT BE RELEASED BY THE PHYSICIAN'S OFFICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention LEAD EXTENSION| ST LINEAR LEAD