BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLTA 1CR 65 CE

    MDR report key: 6082197 · Received November 7, 2016

    Report

    Report Number
    1028232-2016-04265
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    September 10, 2016
    Report Date
    October 24, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN CAREFULLY ANALYZED. THE PROVIDED IEGM WAS INVESTIGATED. THEREBY REGULAR SIGNALS WERE NOTED ON THE VENTRICULAR CHANNEL WHICH COULD BE IDENTIFIED AS INTRINSIC VENTRICULAR SIGNALS. IN BETWEEN THESE INTRINSIC SIGNALS SENSED ARTIFACTS WERE OBSERVED WHICH WERE SYNCHRONOUS WITH THE ATRIAL CONTRACTION. HOWEVER, WITHOUT FURTHER INFORMATION, DIAGNOSTIC IMAGES AND AN ANALYSIS OF THE LEAD ITSELF, NO DEFINITE CONCLUSION CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION. SHOULD ADDITIONAL INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE FOR ANALYSIS, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION PERIOD OF 37 MONTHS VENTRICULAR OVERSENSING WAS REPORTED. NO INAPPROPRIATE THERAPY WAS DELIVERED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732646 VOLTA 1CR 65 CE ICD LEAD NVY BIOTRONIK SE & CO. KG 384074

    Patients

    Seq Age Sex Outcome Treatment
    1