BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALLINE

    MDR report key: 3152496 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01547
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 22, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-IMPLANT, THE PATIENT EXPERIENCED MYOCARDIAL PERFORATION. THE LEAD WAS 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
    252764 CRYSTALLINE ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG ICQ09B

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R