BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 3040753 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02163
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    June 1, 2012
    Report Date
    January 16, 2013
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRIOR TO EXPLANT, THIS LEAD ALSO EXHIBITED LOSS OF CAPTURE AND POOR SENSING. DUE TO THE HIGH OOR IMPEDANCES AND THE IMPAIRED FUNCTION OF THE LEAD IT WAS SUSPECTED THAT THE LEAD WAS FRACTURED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH, OUT OF RANGE PACING IMPEDANCES GREATER THAN 2500 OHMS AND NOISE. ADDITIONALLY THERE WAS CONCERN RELATED THE PACEMAKERS FLUCTUATING BATTERY LONGEVITY READINGS IN THIS DEPENDENT PATIENT. GIVEN THE ISSUES WITH THE RA LEAD AND THE FLUCTUATING BATTERY LONGEVITY SURGICAL INTERVENTION WAS PERFORMED. THE RA LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS SUCCESSFULLY EXPLANTED. A NEW LEAD AND GENERATOR WERE SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143299 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4271

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R 4271| 1290| 4261| 1283| 0950