BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITA 2 DDD

    MDR report key: 1861822 · Received October 8, 2010

    Report

    Report Number
    6000094-2010-01868
    Event Type
    Injury
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS FURTHER REPORTED THAT THE PATIENT HAD SWOLLEN LEGS FOR ONE MONTH AND THE PHYSICIAN THOUGHT IT WAS A SIGN OF THE PACEMAKER BEING AT ERI AND THE PHYSICIAN SUGGESTED THE PACEMAKER REPLACEMENT TO TREAT THE SWELLING. THE PACEMAKER WAS EXPLANTED AND REPLACED AND THE PATIENT WAS REPORTED TO BE GOOD NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITA 2 DDD IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 730 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention