BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-P

    MDR report key: 2203571 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01534
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 26, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    OJX
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(6) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT AFTER IMPLANT, WHEN PROGRAMMING THE DEVICE, AN ELECTRICAL RESET OCCURRED AND THE BATTERY VOLTAGE HAD DECREASED FROM 3.01 VOLTS TO 2.87 VOLTS. THE POCKET WAS REOPENED AND THE DEVICE WAS REPLACED WITH A NEW ONE. IT WAS FOUND THAT THE PROGRAMMING OF THE VENTRICLE RATE LIMIT TRIGGERED THE RESETS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA CRT-P IMPLANTABLE PULSE GENERATOR OJX MEDTRONIC S.A. C3TR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R