BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELOX SR 53

    MDR report key: 728342 · Received June 14, 2006

    Report

    Report Number
    1028232-2006-00030
    Event Type
    Other
    Date Received
    June 14, 2006
    Date of Event
    June 3, 2006
    Report Date
    June 13, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    p950037
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON ALL THE INFO AVAILABLE FOR THIS DEVICE AND THE RESULTS OF THE TEST MEASUREMENTS, IT IS CONFIRMED THAT THE DEVICE IS FUNCTIONING AS SPECIFIED. 510 (P) NUMBER IS P950037.

    Description of Event or Problem · 1

    LEAD DISLODGED, REPLACED WITH ACTIVE FIXATION LEAD. BIOTRONIK HAS NOT RECIEVED ANY FURTHER INFO ABOUT PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX SR 53 PACEMAKER LEAD LWS BIOTRONIK GMBH AND CO. 346 366 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR