BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART PROMRI S DX 65/15

    MDR report key: 5162642 · Received October 20, 2015

    Report

    Report Number
    1028232-2015-03851
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    September 22, 2015
    Report Date
    October 8, 2015
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED WAS CAREFULLY ANALYSED. THE AVAILABLE IMPEDANCE TRENDS DEMONSTRATED A STABLE LEAD IMPEDANCE OF ABOUT 400 OHM AND A STABLE SHOCK IMPEDANCE OF APPROX. 90 OHM BETWEEN (B)(6) 2015 AND (B)(6) 2015. THE AVAILABLE IEGMS CONFIRMED THE PRESENCE OF NOISE ON THE RA AND THE FF CHANNEL AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN SPITE OF THE INFORMATION AVAILABLE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN REGARDING THE ROOT CAUSE FOR THE CLINICAL OBSERVATION. AN ANALYSIS OF THE LEAD WOULD BE NECESSARY FOR A ROOT CAUSE INVESTIGATION. SHOULD ADDITIONAL INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE FOR ANALYSIS, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT OVERSENSING IN ATRIUM AND FAR FIELD WAS NOTED. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED AND NO INDICATION WAS GIVEN THAT THIS DEVICE WAS REVISED OR EXPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692219 LINOX SMART PROMRI S DX 65/15 ICD LEAD NVY BIOTRONIK SE & CO. KG 377211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other