BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1850883 · Received September 28, 2010

    Report

    Report Number
    3006630150-2010-01660
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 30, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEADS WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT HAS AN INFECTION AT THE LEAD SITE. THE PT'S SYMPTOMS WERE DRAINAGE FROM THE WOUND. THE PHYSICIAN EXPLANTED THE PT'S LEADS AND PRESCRIBED THE PT ORAL ANTIBIOTICS. THE PHYSICIAN IS NOT SURE IF THE INFECTION IS PROCEDURE OR DEVICE RELATED. THE PT IS DOING WELL FOLLOWING THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SERIAL #: (B)(4)| ENH ST LD KIT: MODEL #: SC-2218-50,