BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 2964536 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02116
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 27, 2012
    Report Date
    February 18, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PRODUCT EVENT SUMMARY - THE FULL LEAD WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE STYLET WAS NOT ABLE TO BE REMOVED FROM THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS REMOVED FROM THE PATIENT AND STILL THE STYLET WAS UNABLE TO BE REMOVED FROM THE LEAD. THE RV LEAD WAS NOT USED AND A DIFFERENT RV LEAD WAS IMPLANTED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67990 DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR