BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLYROX 53/15 BP

    MDR report key: 736808 · Received July 17, 2006

    Report

    Report Number
    1028232-2006-00133
    Event Type
    Other
    Date Received
    July 17, 2006
    Date of Event
    January 1, 2006
    Report Date
    July 11, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    p950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PACING SYSTEM EXPLANTED DUE TO INFECTION. LEAD LASER EXTRACTED. PT HAD PREVIOUS POCKET REVISIONS. ALSO INVOLVED ARE A PHILOS DR ACC, MDR 06-0131 AND POLYROX 45, MDR 06-132. 7/13/2006, REP REPORTED THAT THE INFECTION CLEARED AND THE PT WAS IMPLANTED WITH A NEW SYSTEM TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYROX 53/15 BP BRADYCARDIA LEAD DTB BIOTRONIK GMBH AND CO. 130 050 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization