BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 3083060 · Received April 29, 2013

    Report

    Report Number
    1028232-2013-01136
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 15, 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

    THE DEVICE WAS EXPLANTED DUE TO HEMATOMA. 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. THE BIOTRONIK STERILIZATION PROTOCOL CONFIRMED THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., WERE IN THEIR SPECIFIED RANGES. ALSO, THE INVESTIGATION OF THE MICROBIOLOGICAL INDICATORS SHOWED THE SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS. IN SUMMARY, THE HEMATOMA WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    "PATIENT IS ON COUMADIN AND DEVELOPED A HEMATOMA AFTER IMPLANT. THE HEMATOMA WAS EVACUATED, BUT THE SKIN INTEGRITY OF THE POCKET WOULD NOT ALLOW FOR PROPER HEALING. THE PATIENT HAD AN OPEN INCISION FOR SEVERAL DAYS BEFORE CONTACTING THE PHYSICIAN. THE PATIENT ALSO HAS A MECHANICAL AORTIC VALVE. NO INFECTION HAS CURRENTLY BEEN CONFIRMED AT THIS TIME. THE ENTIRE SYSTEM FROM THE LEFT SIDE WAS REMOVED AND REPLACED WITH A NEW SYSTEM ON THE RIGHT SIDE TO AVOID THE POSSIBLE SPREAD OF INFECTION THROUGHOUT THE HEART AND TO THE MECHANICAL VALVE." THE HOSPITAL RETAINED THE DEVICES. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185267 SETROX S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization