BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART PROMRI DF4 SD 65/16

    MDR report key: 3211814 · Received July 8, 2013

    Report

    Report Number
    1028232-2013-01863
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 27, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LEAD WAS THOROUGHLY ANALYZED. DURING THE EXAMINATION, THE LEAD WAS CHECKED VISUALLY, ELECTRICALLY, AND MECHANICALLY. DURING THE VISUAL INSPECTION, DEFORMATIONS OF THE PROXIMAL AND DISTAL SHOCK COILS AND A DEFORMATION OF THE RING ELECTRODE ARE NOTED, WHICH ARE PROBABLY A RESULT OF THE OPERATION. THE CONTINUING ANALYSIS DID NOT SHOW ANY FURTHER DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. THE LEAD PROVED TO BE IN CONFORMANCE WITH SPECIFICATIONS AND WITHOUT PROBLEMS. IN SUMMARY, THERE WERE NO INDICATIONS OF MATERIAL OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - INTRAOPERATIVE AND DISCHARGE VALUES WERE AT ABOUT 12.0MV FOR THIS RV LEAD. A FEW DAYS LATER ABRUPT CHANGES OF ABOUT 2.0 MV WERE NOTED VIA HOME MONITORING. THERE WERE NO SIGNIFICANT CHANGES IN EITHER THE IMPEDANCE OR PACING THRESHOLD. THE LEAD STILL SHOWS IT HAS NOT MOVED FROM WHERE IT WAS IMPLANTED. THE LEAD WAS REVISED AND ATTEMPTS TO REPOSITION WERE UNSUCCESSFUL DUE TO OVERSENSING AT 31.05. THE HELIX WAS NOT STABLE. THEREFORE, THE LEAD WAS EXPLANTED AND REPLACED WITH AN IDENTICAL LEAD IN AN APICAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308883 LINOX SMART PROMRI DF4 SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 394102

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization