BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2953446 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01114
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 6940 IMPLANTABLE DEFIB LEAD 1999 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4) PERFORMANCE DATA FROM THE DEVICE WAS ANALYZED AND REVEALED A RISING RV PACING IMPEDANCE TREND AND AN OUT OF RANGE LEAD IMPEDANCE ALERT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUPERIOR VENA CAVA (SVC) LEAD IMPEDANCE WARNING WITH READINGS READINGS FLUCTUATING BY 20 OHMS AND RIGHT VENTRICULAR (RV) IMPEDANCE MEASUREMENTS OF 44, 63 AND 48 OHMS. IT WAS ALSO REPORTED THAT DURING TESTING RAISING THE PATIENT'S ARM RESULTED IN RV AND SVC IMPEDANCES OUT OF RANGE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUPERIOR VENA CAVA (SVC) LEAD IMPEDANCE WARNING WITH READINGS READINGS FLUCTUATING BY 20 OHMS AND RIGHT VENTRICULAR (RV) IMPEDANCE MEASUREMENTS OF 44, 63 AND 48 OHMS. IT WAS ALSO REPORTED THAT DURING TESTING RAISING THE PATIENT'S ARM RESULTED IN RV AND SVC IMPEDANCES OUT OF RANGE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57831 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR (B)(4) IMPLANTABLE DEFIBRILLATOR