BEUDAMED
    FDA Adverse Event Other Summary report: N

    SETROX S 53

    MDR report key: 2860311 · Received November 21, 2012

    Report

    Report Number
    1028232-2012-02931
    Event Type
    Other
    Date Received
    November 21, 2012
    Date of Event
    October 18, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL ANALYSIS. THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. MERELY SLIGHT SIGNS OF ABRASION WERE FOUND ALONG THE LEAD BODY. THE CUTTINGS OF THE INSULATION RESULTED MOST LIKELY FROM THE EXPLANTATION PROCEDURE. DURING THIS ANALYSIS, NO FURTHER DEVIATIONS WERE NOTED. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS SYSTEM WAS EXPLANTED ON (B)(6) 2012 BECAUSE THE PATIENT CHOSE TO HAVE IT REMOVED. THE PATIENT DID NOT WANT THE DEVICE ANYMORE. THERE ARE NO KNOWN COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE. THERE ARE NO KNOWN ADVERSE EVENTS REPORTED FOR THIS PATIENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other