BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTOVIS HF-T PROMRI

    MDR report key: 3122278 · Received May 21, 2013

    Report

    Report Number
    1028232-2013-01406
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE 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

    OUS MDR - A HEMATOMA DEVELOPED AFTER THE IMPLANT. THIS IS ALL OF THE AVAILABLE INFORMATION PROVIDED TO US. THERE WAS NO INDICATION OF ANY INTERVENTION. THE EVENT DATE WAS NOT PROVIDED. ALL AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS ACTIVELY IMPLANTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223863 ENTOVIS HF-T PROMRI CRT-P NKE BIOTRONIK SE & CO. KG 381530

    Patients

    Seq Age Sex Outcome Treatment
    1 Other