BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 2953685 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01330
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THERE WAS A PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 14:09:26 AND 2 LEAD PREDICTOR FAILURE HIGH RATE NS <(><<)>= 200 MS AVERAGE V-CYCLE ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT VENTRICULAR (RV) LEAD REVISION PROCEDURE FOR INCREASED PACING THRESHOLDS, IT WAS FOUND THAT THE DEVICE IMPLANTED 9 MONTHS AGO HAD A BLOCKED RV SETSCREW. IT WAS ALSO REPORTED THAT THE PHYSICIAN TESTED THE RV LEAD WITH ANALYZER, AND ALL MEASUREMENTS WERE OK. THE DEVICE WAS EXPLANTED AND REPLACED AND THE RV LEAD WAS CONNECTED TO THE NEW DEVICE AND REMAINS INUSE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55729 DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE CRT-D