BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953071 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00868
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 3, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCT: 5054 IMPLANTABLE PACING LEAD 2011 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ECHOCARDIOGRAM REVEALED THAT THERE WAS OVERSENSING WITH THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS. IT WAS ALSO REPORTED THAT THE OVERSENSING WAS VISIBLE WITH ISOMETRICS. IT WAS FURTHER REPORTED THAT THE OVERSENSING DISAPPEARED WITH A CHANGE IN CONFIGURATION FROM BIPOLAR TO UNIPOLAR. THERE WAS ALSO A REPORT OF COAT DAMAGE TO THE LEAD AND LEAD FRICTION WAS SUSPECTED. THE RV AND RA LEADS REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55526 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER