BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2011-07627

    MDR report key: 2153678 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-07627
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THERE IS NO ADDITIONAL INFORMATION AVAILABLE AND OUR INVESTIGATION IS COMPLETE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE LEAD NEEDED TO UNDERGO AN MAGNETIC RESONANCE IMAGING (MRI). THE PATIENT REPORTED THAT THEY HAD A HEART TRANSPLANT IN 2009. EVERYTHING WAS REMOVED, BUT A SMALL SECTION OF THE LEAD. THE PORTION OF THE LEAD REMAINS IN THE PATIENT'S LEFT SHOULDER/NECK AREA. THE LOCAL HEALTH CARE PROVIDER CONFIRMED THAT DURING THE EXPLANT PROCEDURE, THE PHYSICIAN HAD DIFFICULTIES PULLING THE LEAD OUT. THE LEAD BEGAN TO UNRAVEL AND THE DECISION WAS MADE TO LEAVE THE PORTION OF THE LEAD IN THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVY GUIDANT PUERTO RICO BV TACHY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other 0157| 1861| 4470| H175| 4525