BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-L 85-BP

    MDR report key: 3021801 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00748
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 11, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT RETURNED TO CLINIC SEVERAL TIMES FOR DIAPHRAGMATIC STIMULATION. THE DEVICE WAS REPROGRAMMED WITH TEMPORARY RESOLUTION OF SYMPTOMS BUT THE PATIENT HAD TO RETURN WITH REAPPERANCE OF DIAPHRAGMATIC STIMULATION. ALL OPTIONS EXHAUSTED AND DECISION MADE TO TURN OFF BIV THERAPY TEMPORARILY AND TO REVISE THE LEAD (SCHEDULED FOR (B)(6) 2013). CURRENTLY, ALL AVAILABLE INFORMATION SUGGESTS THIS LEAD REMAINS IMPLANTED. IF ADDTIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123684 COROX OTW-L 85-BP LV LEAD NKE BIOTRONIK SE & CO. KG 368346

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other