BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2953514 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00257
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 28, 2011
    Report Date
    December 4, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    OJX
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4). CONCOMITANT PRODUCT: 6932 IMPLANTABLE TACHY LEAD: (B)(6) 2002; 4189 IMPLANTABLE PACING LEAD: (B)(6) 2001. THE PHYSICIAN DIDN'T HAVE ANY COMPLAINT WITH THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A POCKET INFECTION. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56715 CONSULTA CRT-D OJX IPG MFG SWITZERLAND D234TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R 4568 IMPLANTABLE PACING LEAD