BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD 2

    MDR report key: 6008476 · Received October 6, 2016

    Report

    Report Number
    2649622-2016-12222
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    July 20, 2016
    Report Date
    August 2, 2016
    Manufacturer
    MPRI
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POLARITY SWITCH DUE TO LOW IMPEDANCE. THE PATIENT HAD ALSO COMPLAINED OF THUMPING AT THE IMPLANT SITE FROM UNIPOLAR PACING. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654508 CAPSURE VDD 2 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MPRI 5038-58

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R (B)(4) IPG