BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    MDR report key: 2953655 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01277
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 16, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. PRODUCT EVENT SUMMARY: THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE HELIX WAS ABLE TO BE EXTENDED AND RETRACTED WITHIN SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE IN THE PROCEDURE AN EXTENSION AND RETRACTION TEST OF THE ATRIAL LEAD'S HELIX WAS TESTED ON THE TABLE. THE HELIX DID NOT EXTEND EVEN THOUGH IT WAS ROTATED OVER TEN TIMES. FINALLY THE HELIX SLOWLY EXTENDED AND RETRACTED, BUT IT HAD BEEN ROTATED ABOUT THIRTY TIMES IN THREE PARTS. THE PHYSICIAN FELT UNCOMFORTABLE USING THIS LEAD CLINICALLY AFTER THE TEST DUE TO THIS WAS A STRAIGHT CONDITION TEST WITH A STRAIGHT STYLET AND THE HELIX NEEDED ABOUT THIRTY ROTATIONS IN ORDER TO EXTEND AND RETRACT. THEREFORE, THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57800 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR