BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-L 85-BP

    MDR report key: 2190086 · Received June 29, 2011

    Report

    Report Number
    1028232-2011-01443
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    April 12, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BIOTRONIK, SE & CO KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 10 MONTHS, A PACING IMPEDANCE OF >3000 OHMS WAS REPORTED AND THE DEVICE WAS EXPLANTED. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW-L 85-BP LV LEAD NKE BIOTRONIK, SE & CO KG 368349

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization