BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 3040870 · Received April 8, 2013

    Report

    Report Number
    1028232-2013-00941
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 25, 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 WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION WHICH OCCURRED MOST LIKELY DURING SURGERY. DURING FURTHER ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITHOUT OOS DOCUMENTATION. MEDTRONIC, BOSTON SCIENTIFIC, ST JUDE MEDICAL AND SORIN MEDICAL HAVE NO RECORD OF THIS PATIENT. THE FOLLOWING PHYSICIAN'S OFFICE WOULD NOT RETURN PHONE CALLS. THE HOSPITAL HAS NO RECORD OF THIS PATIENT. RECORDS INDICATE THAT THIS PATIENT WAS LIVING IN A BEHAVIOR CENTER; HOWEVER THEIR RECORDS INDICATE THAT THE PATIENT HAS NOT BEEN IN THEIR FACILITY FOR TWO YEARS. THE DATE AND REASON FOR EXPLANT ARE UNKNOWN. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PATIENT. THERE ARE NO KNOWN COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142694 SETROX S 45 PACER LEAD NVN BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization