BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953750 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01282
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 16, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE THE LEAD TESTED GOOD IN ALL PARAMETERS AFTER BEING IMPLANTED. HOWEVER, WHEN IT WAS CONNECTED TO THE DEVICE THERE WAS NO PACING. THE PHYSICIAN DISCONNECTED THE LEAD AND TRIED TO RE-IMPLANT THE LEAD, BUT THE PATIENT SUDDENLY HAD ACUTE HEART FAILURE. FOR THE PATIENT'S SAFETY THE PHYSICIAN CAPPED THE LEAD AND IMPLANTED A NEW LEAD INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57437 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R