BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2911884 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16308
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    August 28, 2007
    Report Date
    December 3, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO NOISE PRESENT, EVEN WHILE TESTING WITH POCKET MANIPULATIONS. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED AND THE PATIENT CONVERTED WITH A 17 JOULE SHOCK. NO ADDITIONAL CHANGES TO THE SYSTEM PLANNED TO BE PERFORMED. THE PHYSICIAN PLANNED TO BE MONITOR THE PATIENT REMOTELY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACING IMPEDANCES MEASUREMENTS FOR THIS RIGHT VENTRICULAR (RV) LEAD HAD INCREASED FROM 600 OHMS TO APPROXIMATELY 1,400 OHMS. ADDITIONALLY, PACING THRESHOLD MEASUREMENTS HAD GRADUALLY INCREASED FROM 1.0 V AT 0.5 MS TO 1.8 V AT 0.5 MS. APPROXIMATELY FIVE YEARS LATER, WE RECEIVED INFORMATION THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AS A RESULT OF RECEIVING AN INAPPROPRIATE SHOCK. IT WAS REPORTED THAT MASSAGING ELECTRODES WERE PLACED ON THE PATIENT WHILE AT THE CHIROPRACTOR. THE ELECTRODES WERE OVERSENSED AS NOISE AND A SHOCK WAS DELIVERED. NO PAUSES IN PACING WERE NOTED AS A RESULT OF THE NOISE FROM THE ELECTRODES. AT THE HOSPITAL IT WAS DISCOVERED THAT THE PACING IMPEDANCE HAD INCREASED TO 1,857 OHMS. PACING THRESHOLDS WERE 2.8 VOLTS, HOWEVER, WHEN THE LOCAL AREA SALES REPRESENTATIVE CHECKED THE PACING THRESHOLDS THEY WERE 0.2 VOLTS. THE SALES REPRESENTATIVE DID NOT THINK THE SHOCK VECTOR WAS BEING USED IN THE CONFIGURATION WHEN THE PACING THRESHOLD MEASUREMENTS WERE CHECKED. THE PATIENT IS NOT PACEMAKER DEPENDENT AND HAS A SINUS RHYTHM AT 55 BEATS PER MINUTE (BPM). SINCE LAST DEVICE CHECK, THE PATIENT WAS 1 PERCENT ATRIAL AND VENTRICULAR PACED. IT WAS ALSO NOTED THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). A VENOGRAM WAS PERFORMED WHICH INDICATED THE PATIENT WAS COMPLETELY OCCLUDED ON THE LEFT SIDE. SINCE THE INITIAL IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) APPROXIMATELY THIRTEEN YEARS AGO THE PATIENT HAS HAD NO VENTRICULAR TACHYCARDIA (VT) OR NON-SUSTAINED VT EVENTS. THE ORIGINAL INDICATION FOR THERAPY WAS CARDIOMYOPATHY. THE PHYSICIAN ELECTED NOT TO REPLACE THE RV LEAD AT THIS TIME GIVEN THE PATIENT'S LACK OF NEED FOR THERAPY AND TO AVOID HAVING TO IMPLANT AN ENTIRE NEW SYSTEM ON THE RIGHT SIDE GIVEN THE PATIENT'S CONDITION. THE DEVICE WAS EXPLANTED AND REPLACED. THE RV LEAD REMAINS IN SERVICE WITH THE NEW DEVICE, HOWEVER PACING IMPEDANCES HAVE INCREASED TO GREATER THAN 2,000 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19105 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0144

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR T167| 1388T| 1831| 0144