BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3964987 · Received July 29, 2014

    Report

    Report Number
    2124215-2014-14643
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    May 17, 2014
    Report Date
    April 20, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    AT THIS TIME, THE LEAD HAS NOT BEEN RETURNED. IF THE LEAD IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THAT THIS RV LEAD WAS EXPLANTED DUE TO CHRONICALLY LOW PACING IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS. THE PATIENT HAD A RECENT ATRIOVENTRICULAR (AV) NODAL ABLATION, WHICH CAUSED THE PATIENT TO BECOME PACEMAKER DEPENDENT. THE LEAD HAD BEEN PACING AND SENSING WELL, AND NORMAL CAPTURE WAS NOTED. A SURGICAL REVISION WAS PERFORMED AND THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE 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 LOW, OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS DETECTED VIA THE PATIENT REMOTE MONITORING SYSTEM. IMPEDANCE TREND REVEALED THAT AN OUT OF RANGE MEASUREMENT WAS JUST RECENTLY DETECTED AS PACING IMPEDANCE HAS ALWAYS BEEN IN MID-200 OHMS. FURTHER, ARRHYTHMIA LOGBOOK SHOWED AN EPISODE WITH SOME OVERSENSED NOISE. SUBSEQUENTLY, THE PATIENT WAS BROUGHT IN FOR FURTHER EVALUATION AND NORMAL PACING AND SENSING FUNCTION WITH IMPEDANCE IN AN ACCEPTABLE RANGE WAS OBSERVED. MOREOVER, NOISE COULD NOT BE RECREATED WITH ISOMETRICS. THE PHYSICIAN OPTED TO CLOSELY MONITOR THE PATIENT AND SCHEDULED FOLLOW-UP IN A MONTH. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441511 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 6947| 5076| 0293| 4046| 4593| N161| 6949| MISMATCH| N160| N119| 4194| 4471