BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE LEAD

    MDR report key: 6177995 · Received December 15, 2016

    Report

    Report Number
    2017865-2016-07587
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 25, 2016
    Report Date
    November 25, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED OVERSENSING COULD NOT BE CONCLUSIVELY DETERMINED. (B)(4).

    Description of Event or Problem · 1

    DURING INTERROGATION, NON-SUSTAINED OVERSENSING WAS NOTED ON THE RIGHT ATRIAL LEAD. THE LEAD WAS CAPPED AND REPLACED AND THE PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829209 OPTISENSE LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC. 1999/52 4634711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other