BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953489 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01124
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    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 5076 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DAYS POST IMPLANT THE PATIENT CAME INTO EMERGENCY ROOM WITH SEVERE CHEST PAIN DUE TO MYOCARDIAL PERFORATION. X-RAY WAS PERFORMED AND THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. RV THRESHOLD WAS INCONSISTENT IN BOTH BIPOLAR AND UNIPOLAR, AND R-WAVES WERE LOW. THE RV LEAD WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56556 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| L| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)