BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-S 75-BP

    MDR report key: 1770152 · Received July 19, 2010

    Report

    Report Number
    1028232-2010-01509
    Event Type
    Injury
    Date Received
    July 19, 2010
    Date of Event
    October 22, 2009
    Report Date
    June 29, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MFG.

    Description of Event or Problem · 1

    PER (B) (4) ADVERSE EVENT REPORT, THIS PT DEVELOPED A "BASEBALL SIZED" HEMATOMA POST DEVICE IMPLANT. THE HEMATOMA WAS SUCCESSFULLY DRAINED ON (B) (6)2009, AND THE SYSTEM REMAINS IMPLANTED. SHOULD ADD'L INFO BECOME AVAILABLE, THIS REPORT WILL BE UPDATED. STRATOS LV, (B) (4), MDR 1028232-2010-01507; SETROX S 45, (B) (4), MDR 1028232-2010-01508; SETROX S 45, (B) (4), MDR 1028232-2010-01510.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROX OTW-S 75-BP LV LEAD NKE BIOTRONIK SE & CO. KG 355148

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization