BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 3120370 · Received May 20, 2013

    Report

    Report Number
    1028232-2013-01477
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    March 22, 2012
    Report Date
    April 22, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    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. ITS PERFORMANCE WAS SCRUTINIZED, INCLUDING A VISUAL AND AN ELECTRICAL INSPECTION. THE VISUAL ANALYSIS DEMONSTRATED THAT THE LEAD'S DISTAL PART WAS PULLED OUT OF THE RING ELECTRODE. THEREFORE, THE ADHESIVE RESIDUALS ON THE JOINING SURFACE OF LEAD TIP AND THE LEAD BODY WERE ANALYSED. THE ANALYSIS REVEALED NO INDICATION OF A MATERIAL OR A MANUFACTURING PROBLEM. AS THE ROOT CAUSE OF THE OBSERVED DAMAGE TRACTION FORCES DURING THE SURGERY SHOULD BE TAKEN INTO CONSIDERATION. DURING THE MECHANICAL INSPECTION A STYLET COULD NOT BE PROPERLY INTRODUCED AND ADVANCED WITHIN THE LEAD¿S LUMEN. NEXT, THE LEAD WAS DESTRUCTIVELY ANALYZED AND COAGULATED BLOOD WAS IDENTIFIED IN THE LUMEN OF THE LEAD CAUSING THE INABILITY TO ADVANCE THE STYLET PROPERLY. THESE BLOOD RESIDUALS WERE MOST LIKELY INTRODUCED INTO THE LUMEN OF THE LEAD BY MEANS OF STYLETS USED DURING THE SURGERY. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    WHILE UPGRADING THIS PATIENT TO AN ICD, THE PHYSICIAN CHOSE TO REPLACE THIS LEAD BECAUSE HE "DIDN'T LIKE THE P-WAVES". SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222461 SETROX S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization