BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA CRT-D

    MDR report key: 2053018 · Received April 13, 2011

    Report

    Report Number
    6000094-2011-00517
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 25, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED DEVICE REPLACEMENT, THE DOCTOR RECEIVED A DF-4 PROTECTA DEVICE FROM THE NURSE INSTEAD OF A DF1 PROTECTA DEVICE. THE PHYSICIAN NOTICED THE MISTAKE WHEN TRYING TO CONNECT THE DF1 RV LEAD INTO THE HEADER OF THE DF4 PROTECTA DEVICE. THE PHYSICIAN CLAIMED THAT THE PRODUCT IDENTIFICATION WAS TOO COMPLICATED BECAUSE OF THE SMALL LETTERS. THE DEVICE WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D364TRM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other