BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 53

    MDR report key: 4223056 · Received November 4, 2014

    Report

    Report Number
    1028232-2014-004034
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 24, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED A SQUEEZED INSULATION AT APPROX. 17 CM DISTAL TO THE IS-1 CONNECTOR PIN. IN THIS AREA DEFORMATIONS OF THE INNER AND OUTER CONDUCTOR COILS WERE OBSERVED. IT IS REASONABLE TO ASSUME THAT THESE DAMAGES RESULTED FROM THE USE OF MEDICAL INSTRUMENTS DURING THE SURGERY. FURTHER ANALYSIS OF THE LEAD REVEALED THE PRESENCE OF COAGULATED BLOOD ALONG THE INNER COIL OF THE LEAD. THESE BLOOD RESIDUALS WERE MOST LIKELY INTRODUCED INTO THE LEAD BY MEANS OF STYLETS USED DURING THE SURGERY. IN SUMMARY, A SQUEEZED INSULATION AND DEFORMATIONS OF THE CONDUCTOR COILS WERE OBSERVED, WHICH RESULTED MOST LIKELY FROM THE SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO DAMAGE OF THE OUTER INSULATION OF LEAD. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706167 SETROX S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization