BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD

    MDR report key: 2953329 · Received February 9, 2013

    Report

    Report Number
    6000023-2013-00005
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC, B.V.
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD LOW IMPEDANCE. AN X-RAY CONFIRMED AN APPARENT FRACTURE UNDER THE PATIENT'S CLAVICLE. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57311 CAPSURE VDD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, B.V. 5032S58

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R ADDRS1 IMPLANTABLE PULSE GENERATOR (IPG)