BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3061771 · Received April 16, 2013

    Report

    Report Number
    2124215-2013-06197
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOW PACING IMPEDANCES LESS THAN 200 OHMS. ALSO OBSERVED WERE SOME INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES, AS WELL AS, THRESHOLDS GREATER THAT 2 VOLTS. SURGICAL INTERVENTION WAS PERFORMED AND THE LEAD WAS EXPLANTED AND REPLACED, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. DURING THE PROCEDURE THE PATIENT WAS ALSO UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. IT WAS REPORTED THAT THE LEAD WOULD NOT BE RETURNED AS IT WAS DISCARDED BY THE HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162580 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 5076| 4087| T167| N161| 0184| MISMATCH| 4543| 4592