BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 4163660 · Received October 10, 2014

    Report

    Report Number
    1028232-2014-003710
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    September 26, 2014
    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 FOUND DISSECTED. ONLY 17CM OF THE PROXIMAL FRAGMENT WAS RECEIVED FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED IN THE COURSE OF THE SURGERY. THE RETURNED LEAD FRAGMENT WAS VISUALLY ANALYZED. THE VISUAL INSPECTION REVEALED THAT THE INSULATION WAS, APART FROM THE PRESENT CUTTINGS, FREE OF BREACHES. THE VISUAL INSPECTION DEMONSTRATED A STRETCHED INNER COIL CLOSE TO THE IS-1 CONNECTOR PIN. BASED ON THE CHARACTERISTICS OF STRETCHING, IT IS REASONABLE TO ASSUME THAT THEY WERE CAUSED BY MEANS OF MEDICAL INSTRUMENTS DURING SURGERY. AT A NEXT STEP, THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR LEAD WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. IN SUMMARY, THE LEAD WAS FOUND DISSECTED UPON RECEIPT, WHICH OCCURRED MOST LIKELY DURING THE SURGERY. THE ANALYSIS OF THE AVAILABLE LEAD FRAGMENT DID NOT REVEAL ANY INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS SYSTEM WAS RETURNED WITHOUT DOCUMENTATION. THE PATIENT'S FOLLOWING PHYSICIAN HAD NO RECORD OF THIS SYSTEM EXPLANT AND HAD NOT SEEN THE PATIENT SINCE (B)(6) 2014. THERE ARE NO KNOWN COMPLAINTS AGAINST THE FUNCTIONALITY OF THIS SYSTEM. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640381 SETROX S 45 PACER LEAD NVN BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization