BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 2952697 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00681
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 4, 2012
    Report Date
    February 13, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4): PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED INTERFERENCE/NOISE. THE VENTRICULAR SHORT INTERVAL COUNT WAS ELEVATED TO 42127 COUNTS IN THE TIME BETWEEN (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY : (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THERE WAS BLOOD ON THE DISTAL ELECTRODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD A "DROP" IN R WAVE SENSING SINCE IMPLANT AND AN INCEASE IN PACING THRESHOLD. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56459 DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R (B)(4) IMPLANTABLE DEFIBRILLATOR