BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173181 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10816
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    November 12, 2010
    Report Date
    June 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS TO HAVE A REVISION SCHEDULED. ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    BOTH LEADS WERE LATER EXPLANTED. THE LEFT VENTRICULAR LEAD WAS REPORTED TO BE CRUSHED AT THE POCKET.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT AND LEFT VENTRICULAR LEADS WERE FRACTURED. IN ADDITION, THERE WERE OUT OF RANGE HIGH PACING IMPEDANCES AND A LOSS OF CAPTURE REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 4469| 4542| 0157| H210| 4548| N119