BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 3864996 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01506
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    August 9, 2013
    Report Date
    August 13, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCTS: 5076 LEAD 2013 (B)(6); 3830 LEAD 2013 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A WOUND REVISION WAS PERFORMED DUE TO THE SUPERFICIAL POSITION OF THE LEADS. THE DEVICE WAS REPOSITIONED AND THE DEVICE AND LEADS REMAIN IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) CLINICAL TRIAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341213 PROTECTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D364TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R G0185 LEAD