BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3771553 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-08562
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL OBSERVATION CONFIRMED THAT THE LEAD WAS RETURNED COMPLETELY. A SETSCREW MARK WAS NOTED ON THE TERMINAL PIN. SPIRAL FIXATION IS IN GOOD CONDITION. THE LEAD PASSED CONTINUITY TEST. NO IRREGULARITIES NOTED AT TIP OF THE REGION OF LEAD THAT COULD BE CONTRIBUTED TO DISLODGMENT.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICLE (LV) LEAD WAS PULLED BACK WHEN THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MIGRATED. THE LV LEAD HAD HIGH THRESHOLDS. THE LV LEAD WAS REPOSITIONED BUT WAS UNSUCCESSFUL. THE LV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249372 ACUITY IMPLANTABLE HF LEAD LWP CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R N160| 4135| 0292| 4555| 4592