BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 4150841 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-17338
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 20, 2014
    Report Date
    October 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS PATIENTS HOME MONITORING EQUIPMENT PRODUCED AND ALERT AS THE RIGHT VENTRICULAR (RV) LEAD INTRINSIC AMPLITUDE HAS BEEN OUT OF RANGE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED THAT THE REST OF THE DAILY MEASUREMENTS WERE ALL WITHIN RANGE AND THERE WAS NOTHING ELSE TO SUGGEST ANY LEAD ISSUES. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING INHIBITION WITH MORE THAN TWO SECONDS OF ASYSTOLE DETECTED. UPON INTERROGATION, CROSSTALK OVERSENSING WAS OBSERVED. THE PHYSICIAN ADJUSTED RV SENSITIVITY FROM 0.4 MILLIVOLTS (MV) TO 1.0 MV WHICH ALLEVIATED CROSSTALK OVERSENSING. FURTHER PROGRAMMING AND TROUBLESHOOTING OPTIONS WERE DISCUSSED AND A CHEST X-RAY RESULT REVEALED A HUGE MASS BUT IT WAS NOTHING THAT CAN AFFECT THE FUNCTIONALITY OF THE LEAD. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632436 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 0181| H120| 4086| N141| 4087| 1276| 4591