BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2952607 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00662
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 16, 2012
    Report Date
    February 21, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS OVER-ROTATED, THERE WAS BLOOD ON THE DISTAL ELECTRODE, AND THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST NOTED THAT THE LEAD WAS RETURNED WITH THE DISTAL CONDUCTOR DISTORTED WITHIN THE CONNECTOR. THE DISTAL CONDUCTOR HAS BEEN OVER-ROTATED. WHEN THE HELIX WAS RETRACTED DURING THE PROCEDURE, THE IS-1 CONNECTOR PIN WAS TURNED AN EXCESSIVE NUMBER OF TIMES. THIS PREVENTS PROPER TORQUE TRANSFER WHEN TURNING THE IS-1 PIN.

    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 WHEN THE LEAD WAS PLACED DURING THE IMPLANT PROCEDURE THE HELIX OF THE LEAD WOULD NOT MOVE. THE LEAD WAS REMOVED 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
    57655 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR