BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1830754 · Received September 8, 2010

    Report

    Report Number
    3006630150-2010-01522
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT HAD A LARGE SEROMA AT THE POCKET SITE. THE PATIENT WAS EXPERIENCING SWELLING AND HEAT AT THE POCKET, SO THE PHYSICIAN EXPLANTED THE IPG. FURTHER TESTING REVEALED THAT THE PATIENT HAD AN INFECTION. THE PHYSICIAN EXPLANTED THE PADDLE LEAD, AND THE PATIENT WAS PRESCRIBED VANCOMYCIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R ARTISAN SURGICAL LEAD WITH PLATNALOCK TECHNOLOGY| SERIAL # (B)(4)| 50CM, MODEL # SC-8216-50