BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLTA 1CR 65 CE

    MDR report key: 5210997 · Received November 9, 2015

    Report

    Report Number
    1028232-2015-04034
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    September 28, 2015
    Report Date
    October 28, 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

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. DURING THE VISUAL INSPECTION, CUTS IN THE INSULATION WERE FOUND. IT IS REASONABLE TO ASSUME, THAT THE CUTS RESULTED FROM THE EXPLANTATION PROCEDURE. WITH REGARD TO THE ISSUES MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS OF THE LEAD DID NOT SHOW ANY DEVIATIONS. IN PARTICULAR, THE VALUES OF THE PARAMETERS MEASURED DURING THE MECHANICAL ANALYSIS OF THE FIXATION MECHANISM WERE WITHIN THE TECHNICAL SPECIFICATIONS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. CONCLUSIONS REGARDING THE CLINICAL OBSERVATION CANNOT BE DRAWN FOR THE TIME BEING. THE ANALYSIS WILL CONTINUE AS SOON AS NEW INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THE PATIENT FELL AT HOME 3 DAYS AFTER THE IMPLANTATION. LOSS OF CAPTURE WAS ALSO REPORTED. THE LEAD WAS EXPLANTED BUT NOT RETURNED TO BIOTRONIK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740275 VOLTA 1CR 65 CE ICD LEAD NVY BIOTRONIK SE & CO. KG 384074

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization