BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATOS LV-T

    MDR report key: 2445746 · Received February 7, 2012

    Report

    Report Number
    1028232-2012-00236
    Event Type
    Injury
    Date Received
    February 7, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 26, 2012
    Manufacturer
    BIOTORNIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    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 - TELEMETRY PROBLEMS WERE ENCOUNTERED DURING MEASUREMENT OF THE BATTERY VOLTAGE AND OF THE BATTERY AND LEAD IMPEDANCES AFTER IMPLANTATION IN THE HKL. BEFORE HANDING OVER THE STRATOS, THE BIOTRONIK REP PROGRAMMED THE PM (PACEMAKER) VIA ICS. THIS OCCURRED WITHOUT ANY PROBLEMS. AFTER THE HANDOVER, THE STRATOS WAS FIRST DETECTED BY THE ICS AND SENSING AND "RS" MEASUREMENTS WERE ACCEPTABLE WITH THE EXCEPTION OF THE MEASUREMENT OF THE BATTERY VOLTAGE AND OF THE LEAD AND BATTERY IMPEDANCE. AFTER CONSULTATION WITH TECHNICAL SERVICES IN (B)(4), THE STRATOS WAS EXPLANTED. A NEW STRATOS WAS ATTEMPTED, BUT HAD THE SAME TELEMETRY PROBLEMS. THAT ONE WAS LEFT IN THE PT. A MEASUREMENT OF ALL PARAMETERS WAS POSSIBLE WITHOUT PROBLEMS IN THE CLINIC HALLWAY AFTER LEAVING THE ROOM. THE TELEMETRY OF THE EXPLANTED STRATOS WAS ALSO POSSIBLE AGAIN, HERE, WITHOUT ANY PROBLEMS. THE DOCTOR AND BIOTRONIK HAVE BEEN INFORMED THAT THERE IS AN MRI DEVICE DIRECTLY UNDERNEATH THIS OPERATING ROOM. THE QUESTION WAS RAISED WHETHER THIS COULD HAVE BEEN A SOURCE OF INTERFERENCE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATOS LV-T CRT PACEMAKER (NKE) NKE BIOTORNIK SE & CO. KG 338202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization