BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3904843 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09975
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    October 11, 2007
    Report Date
    April 29, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    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

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS INSPECTED. THE TERMINAL SECTION OF THE LEAD WAS RETURNED SEVERED 17 CENTIMETERS FROM THE TERMINAL PIN. NO IRREGULARITIES NOTED ON THE RETURNED SEGMENT OF LEAD OTHER THAN IT BEING SEVERED. NO FURTHER TESTING WAS PERFORMED. THE CLINICAL OBSERVATION WAS NOT ABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD NEEDED TO BE REPOSITIONED BECAUSE IT HAD DISLODGED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. SUBSEQUENTLY THE LEAD WAS PARTIALLY EXPLANTED FOR AN UNKNOWN REASON AND RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384646 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R H217| 4554| 0184| MISMATCH