BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-S 75 BP

    MDR report key: 1051875 · Received May 21, 2008

    Report

    Report Number
    1028232-2008-00525
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    February 19, 2008
    Report Date
    April 23, 2008
    Manufacturer
    BIOTRONIK, GMBH AND CO
    Product Code
    DTB
    PMA / PMN Number
    P070008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LEAD WERE CHECKED DURING THE ANALYSIS. THE ANALYSIS SHOWED DAMAGE TO THE OUTER INSULATION DUE TO SQUASHING IN A SPATIALLY LIMITED AREA (9 CM DISTAL OF THE LIGATURE). IN ADDITION, THE ELECTRICAL LINES WERE BROKEN AT THIS SPOT. THESE DAMAGE MANIFESTATIONS MUST BE REGARDED AS THE CAUSES FOR THE HIGH PACING IMPEDANCE. THIS DAMAGE MANIFESTATION IS WITH HIGH PROBABILITY THE RESULT OF THE SIMULTANEOUS OCCURRENCE OF STRONG AND EXCESSIVE PRESSURE ON THE LEAD BODY IN THE IMPLANTED STATE. THE CHARACTERISTICS AND THE POSITION OF THE DAMAGE, AS WELL AS THE EXISTING X-RAY IMAGES, INDICATE THE SUBCLAVIAN CRUSH SYNDROME, I.E., THE JAMMING OF THE LEAD BETWEEN CLAVICLE AND FIRST RIB. THE BLOOD IN THE LUMEN OF THE LEAD WAS PROBABLY INTRODUCED DURING THE IMPLANTATION/EXPLANTATION. THE ANALYSIS OF THE DAMAGES AT THE LEAD DID NOT SHOW ANY INDICATIONS FOR MANUFACTURING ERRORS OR MATERIAL DEFECTS.

    Description of Event or Problem · 1

    OUS MDR. A PACING IMPEDANCE OF >3000 OHM WAS REPORTED AFTER AN IMPLANTATION TIME OF ABOUT 7 MONTHS. THE X-RAY IMAGE SHOWED A NOT QUITE CLEAR BEND IN THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW-S 75 BP LV LEAD DTB BIOTRONIK, GMBH AND CO 355148

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization