BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 3002257 · Received March 13, 2013

    Report

    Report Number
    1028232-2013-00723
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION WHICH OCCURRED MOST LIKELY DURING SURGERY. COAGULATED BLOOD WAS FOUND ON THE COIL. THESE BLOOD RESIDUALS WERE MOST LIKELY INTRODUCED INTO THE LUMEN OF THE LEAD BY MEANS OF STYLETS USED DURING THE SURGERY. THE ELECTRICAL INSPECTION COMPRISED THE DYNAMIC MEASUREMENT OF DC RESISTANCES BETWEEN THE RESPECTIVE POTENTIALS. THE PRESENCE OF SHORT CIRCUITS BETWEEN THE POTENTIALS WAS CHECKED. FURTHERMORE, THE PACING IMPEDANCE WAS MEASURED IN A SALINE SOLUTION. NO DEVIATIONS WERE FOUND. IN THE COURSE OF THE ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO LOSS OF CAPTURE AND REPLACED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105809 LINOX SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization