BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 4211037 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003807
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 20, 2014
    Report Date
    October 15, 2014
    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

    ON (B)(6) 2015 - AFTER AN IMPLANTATION PERIOD OF ABOUT 47 MONTHS, IMPEDANCE VALUES > 3000 OHM AND OVERSENSING WERE REPORTED. NO FURTHER DETAILS WITH REGARD TO THIS INCIDENT HAVE BEEN REPORTED TO US. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS. THE RECEIVED FOLLOW-UP DATA, PHOTOS AND X-RAY IMAGES WERE INVESTIGATED. UPON INSPECTION OF THIS DATA THE CLINICAL OBSERVATION WAS CONFIRMED. PACING IMPEDANCE VALUES > 3000 OHMS WERE RECORDED ON (B)(6) 2014. THE PHOTOS CONFIRMED THE LEAD BODY DAMAGE AT THE PROXIMAL PART OF THE LEAD MENTIONED IN THE COMPLAINT DESCRIPTION. NO PECULIARITIES WERE NOTED UPON INSPECTION OF THE X-RAY IMAGES. BASED ON THE INFORMATION AVAILABLE FOR ANALYSIS A LEAD TO CAN INTERACTION CANNOT BE EXCLUDED AS THE ROOT CAUSE OF THE CLINICAL OBSERVATION. HOWEVER, NO CONCLUSIONS CAN BE DRAWN WITHOUT AN ANALYSIS OF THE LEAD ITSELF. SHOULD ADDITIONAL INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE FOR ANALYSIS, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 5 WEEKS, IMPEDANCE VALUES > 3000 OHM AND OVERSENSING WERE REPORTED. NO FURTHER DETAILS WITH REGARD TO THIS INCIDENT HAVE BEEN REPORTED TO US. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD WAS NOT RETURNED TO BIOTRONIK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692467 LINOX SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 Other