BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL 65/16 STEROID

    MDR report key: 2914106 · Received December 7, 2012

    Report

    Report Number
    1028232-2012-03169
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WITH THIS LEAD THAT HAS HAD KNOWN INTERMITTENT RV AND FF NOISE AND WAS BEING FOLLOWED. ON (B)(6) 2012, SHOCK IMPEDANCES GREATER THAN 200 OHMS WERE INDICATED ON HM. IN CLINIC, THEY WERE UNABLE TO PRODUCE A SHOCK IMPEDANCE OF LESS THAN 200 OHMS. IT IS SUSPECTED THAT A CONDUCTOR BREAK HAS OCCURRED AND REPLACEMENT WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTROX SL 65/16 STEROID ICD LEAD LWS BIOTRONIK SE & CO. KG 347351

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other