BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3211007 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08520
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    June 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P050046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILED ANALYSIS IS BEING PERFORMED ON THIS LEAD. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL OBSERVATION CONFIRMED THAT THE COMPLETE LEAD WAS RETURNED WITH DRIED BLOOD/BODILY FLUID IN THE LEAD LUMEN. THE CONDUCTOR COILS WERE FOUND TO BE DEFORMED, MOST LIKELY DUE TO THE DRIED BODILY FLUIDS. THERE WAS ELECTROCAUTERY DAMAGE FOUND ON THE INSULATION. THE DISLODGMENT OBSERVATION COULD NOT BE CONFIRMED BY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DEPENDANT PATIENT EXPERIENCED A GREATER THAN 4 SECOND PAUSE IN PACING WHICH LEAD TO ANTI-TACHYCARDIA PACING (ATP). THERE WAS ALSO NOISE PRESENT ON THE ON THE RIGHT VENTRICULAR (RV) LEAD, AS WELL AS OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE LV LEAD WAS FOUND TO HAVE BEEN DISLODGED AND HAD LOSS OF CAPTURE (LOC). THE DEVICE, THE RV AND LV LEAD WERE REMOVED AND REPLACED. A NON BOSTON SCIENTIFIC LEAD WAS USED IN THE LV THAT WOULD NOT FIT IN THE CHRONIC DEVICE.TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311268 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 0181| 4054| 4555| N119