BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953349 · Received February 9, 2013

    Report

    Report Number
    3008973940-2013-00014
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FIRST FOLLOW UP APPOINTMENT AFTER IMPLANT AND HAD HIGH, UNSTABLE THRESHOLDS OF THE RIGHT VENTRICULAR (RV) LEAD. A SCAN INDICATED THAT THE RV LEAD HAD PERFORATED THE MYOCARDIUM. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56899 ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 407458

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| L| R