BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3210034 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09739
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION NOTED THAT THIS LEAD WAS EXPLANTED AND WILL NOT BE RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT LOST CONSCIOUSNESS AT HOME AND WAS FOUND TO BE IN ASYSTOLE WHEN AMBULANCE OFFICERS ARRIVED. THE PATIENT WAS GIVEN CARDIORESPIRATORY RESUSCITATION AND TRANSPORTED TO A HOSPITAL WHERE A PACING WIRE WAS INSERTED, AS THE PATIENTS HEART RATE WAS RECORDED AT AROUND 30 BPM. ANALYSIS OF THE PACEMAKER REVEALED THAT THE VENTRICULAR LEAD IMPEDANCE HAD SUDDENLY SPIKED TO >2500 OHMS AS OF (B)(6) 2014, THE DAY THE PATIENT COLLAPSED. PREVIOUS VENTRICULAR LEAD IMPEDANCE VALUES IN THE DAILY MEASUREMENTS HAD ALL BEEN WITHIN RANGE & THERE WAS NO SIGN OF ANY CONDUCTOR FRACTURE. ANALYSIS OF THE ARRHYTHMIA LOGBOOK REVEALED LOSS OF VENTRICULAR CAPTURE AS EARLY AS 1400 HOURS ON (B)(6) 2013, HOWEVER THE PATIENT WAS NOT IN COMPLETE HEART BLOCK AT THIS POINT IN THE DAY. IT WAS ONLY WHEN THE PATIENT WENT INTO COMPLETE HEART BLOCK AT AROUND 1900 HOURS LATER THAT EVENING THAT THE FAILURE OF THE VENTRICULAR LEAD RESULTED IN THE PATIENT'S LOSS OF CONSCIOUSNESS. THE PACEMAKER CHECK REVEALED NO CAPTURE OF THE VENTRICLE AT 10 VOLTS. THE SAFETY SWITCH ON THE RV LEAD HAD BEEN TRIGGERED AND THE LEAD HAD SWITCHED TO UNIPOLAR PACING/SENSING. DESPITE THIS, THE IMPEDANCE WAS STILL >2500 OHMS. THE PACING WIRE WAS TO REMAIN IN PLACE UNTIL THE PATIENT UNDERGOES A LEAD REPLACEMENT. MANUAL POCKET MANIPULATION DID RESULT IN SOME NOISE ON THE RV LEAD. THE PATIENT REPORTED THAT HE HAD BEEN ON THE RIDE ON LAWN MOWER FOR SOME TIME EARLIER IN THE DAY, WITH HIS ARMS OUTSTRETCHED ON THE STEERING WHEEL. IT WAS HYPOTHESISED THAT A SUBCLAVIAN CRUSH MAY HAVE CAUSED CONDUCTOR DAMAGE IN THE LEAD, HOWEVER X-RAY DID NOT SHOW ANY VISIBLE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309195 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L