BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1861542 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10035
    Event Type
    Injury
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE FIDELIS DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) PACE SENSE AND LEFT VENTRICULAR (LV) LEADS WERE SWAPPED PROACTIVELY AT LAST CHANGE OUT EVEN THOUGH THE RV LEAD WAS PERFORMING NORMALLY. THIS IS AN OFF LABEL SYSTEM SET-UP. CURRENTLY, THEY ARE SEEING OVERSENSING OF MYOPOTENTIALS AND INHIBITION OF PACING DUE TO OVERSENSING ON THE LV LEAD. AT PRIOR FOLLOW-UP, THE PATIENT WAS HAVING SYMPTOMS DUE TO INHIBITION AND THE SENSITIVITY WAS CHANGED TO 1.2MV IN ORDER TO GET RID OF OVERSENSING. HOWEVER, THERE WERE STILL EPISODES WITH INHIBITION. BOTH LEADS ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB