BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART SD 65/16

    MDR report key: 4211002 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003811
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR - MULTIPLE INAPPROPRIATE SHOCKS WERE NOTED. THE IEGM SHOWS MARKS OF BOTH ATRIAL AND VENTRICULAR SIGNALS IN THE VENTRICULAR CHANNEL AND RESULTING ERRONEOUS DETECTION OF VF. WITH X-RAY CHECK A VENTRICULAR LEAD DISLODGEMENT WAS CONFIRMED. THE PATIENT UNDERWENT LEAD REPOSITIONING ON (B)(6) 2014, BUT DUE TO THE COHESIONS OF THE LEAD IN THE SUBCLAVIAN AREA IT WAS NOT POSSIBLE TO MOVE IT. THEREFORE A NEW LEAD WAS INSERTED WITH A NEW VEIN PUNCTURE ON THE OPPOSITE SITE (LEFT ACCESS WAS OCCLUDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692038 LINOX SMART SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 359066

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization