BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE

    MDR report key: 843454 · Received April 26, 2007

    Report

    Report Number
    MW1042726
    Event Type
    Other
    Date Received
    April 26, 2007
    Date of Event
    November 1, 2006
    Report Date
    April 26, 2007
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A HEART CATH AND WAS NOT TOLD BY MY DR THAT HE WAS GOING TO USE A STARCLOSE DEVICE. THE LITERATURE STATED YOU SHOULD EXPECT PAIN FOR A COUPLE OF DAYS, NO LONGER THAN A WEEK. AFTER A WEEK I WENT TO MY DR AND HE SAID THE PAIN COULD LAST 6 WKS. IT TOOK 3 MONTHS BEFORE THE PAIN WENT AWAY. IT WAS TRIGGERED AGAIN AFTER I HAD TRACTION FOR MY BACK. I BELIEVE THE TRACTION BELT THAT WENT ACROSS MY GROIN (SURGICAL SITE) CAUSED THE PAIN TO RETURN. I STOPPED TRACTION AND WENT TO PHYSICAL THERAPY. I FOUND OUT AT PHYSICAL THERAPY THAT WHEN I LIED ON A BENCH TO DO LEG LIFTS (WITH MY GROIN ON THE TABLE AND LEGS OFF) IT TRIGGED THE PAIN AGAIN. FOR THE PAST 6 MONTHS I HAVE HAD PAIN FOR FIVE, THE PAIN RADIATES DOWN MY THIGH AND TO THE HIP, ALONG WITH THE TENDON DIRECTLY UNDER THE GROIN. I HAVE ASKED THE DR TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE * MGB ABBOTT VASCULAR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other