BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELLENCE+

    MDR report key: 2964703 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02018
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 PRODUCTS: KDR701 IMPLANTABLE PULSE GENERATOR (B)(6) 2006, IMB49B58 IMPLANTABLE PACING LEAD (B)(6) 1999. (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 THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD HAD LEAD WARNINGS. IT WAS NOTED THAT THE PATIENT DID HAVE A COMPUTER AIDED TOMOGRAPHY (CAT) SCAN RECENTLY AND THAT THE REPORTED THOUGHT THE RA AND RV LEAD IMPEDANCE AND THRESHOLDS WERE GOOD. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE. THE RA AND THE RV LEADS REMAIN 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
    68686 EXCELLENCE+ DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI IMD49JB53

    Patients

    Seq Age Sex Outcome Treatment
    1 310C31 TISSUE VALVE