BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINOX SD 65/18

    MDR report key: 2288598 · Received October 5, 2011

    Report

    Report Number
    1028232-2011-02262
    Event Type
    Other
    Date Received
    October 5, 2011
    Date of Event
    September 20, 2011
    Report Date
    September 20, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    10/26/15 - THIS LEAD WAS EXPLANTED, BUT WAS NOT RETURNED. ADDED THE EXPLANT DATE. 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

    THE PT WAS INAPPROPRIATELY SHOCKED MANY TIMES DUE TO NOISE ON THE LEAD. THE LEAD IMPEDANCE ON THE RV LEAD IS GREATER THEN 150 OHMS. EXPLANT OF THIS DEVICE IS SCHEDULED TO HAPPEN. THE DOCTOR SUSPECTS A LEAD FRACTURE AS A RESULT OF THE PT PERFORMING HEAVY LABOR. SHOULD ADD'L INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other