BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 4832567 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07487
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 20, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    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 PATIENT'S LEAD WAS UNABLE TO ATTACH TO THE MYOCARDIUM AND SLID OUT OF THE MOUTH OF THE IMPLANTATION TOOL. THE PHYSICIAN SUGGESTED THAT THE LEAD POSSIBLY BECAME DISLODGED FROM THE INSERTION TOOL DUE TO PATIENT FAT. THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. THE NEW LEAD INITIALLY SLID OUT OF THE MOUTH OF THE IMPLANTATION TOOL BUT WAS SUCCESSFULLY IMPLANTED WITH THE USE OF A HEMOSTATIC CLAMP. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373679 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR