BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 53

    MDR report key: 3843196 · Received June 2, 2014

    Report

    Report Number
    1028232-2014-01806
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 19, 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 WAS FOUND DISSECTED AT 11 CM DISTAL TO THE IS-1 CONNECTOR PIN. ONLY THE PROXIMAL FRAGMENT WAS RECEIVED. THE RETURNED FRAGMENT WAS VISUALLY AND ELECTRICALLY ANALYZED. THE INSPECTION OF THE INSULATION CONFIRMED THAT THE LEAD WAS, APART FROM THE PRESENT CUTTINGS, FREE OF INSULATION BREACHES. IN ADDITION, THE DC RESISTANCES OF THE CONDUCTOR FRAGMENTS WERE INVESTIGATED. NO PECULIARITIES WERE FOUND. THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. WITH REGARD TO THE THRESHOLDS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS OF THE AVAILABLE FRAGMENT DID NOT SHOW ANY DEVIATIONS. IN SUMMARY, NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM WAS NOTED DURING ANALYSIS.

    Description of Event or Problem · 1

    THIS LEAD WAS CAPPED AND REPLACED DUE TO HIGH THRESHOLDS. A PORTION OF THE LEAD WAS RETURNED. THE PACEMAKER WAS ALSO CHANGED OUT AT THE SAME TIME DUE TO ERI. 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
    321285 SETROX S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization