BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3191657 · Received June 26, 2013

    Report

    Report Number
    3006630150-2013-01310
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A POSSIBLE INFECTION AT THE POCKET SITE. SYMPTOMS INCLUDE SWELLING AND A SCAB THAT HAD PEELED OFF AT THE SITE. THE PATIENT UNDERWENT A POCKET REVISION WHEREIN THE PHYSICIAN TOOK OUT THE IPG, WASHED THE SITE, PLACED THE IPG BACK IN, AND RESUTURED THE SITE. THE PATIENT WAS PRESCRIBED WITH PROPHYLACTIC ANTIBIOTICS. THE PHYSICIAN DETERMINED THAT THE POCKET SITE WAS NOT INFECTED. THE PATIENT WAS DOING WELL AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290201 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R