BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2813180 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17225
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) THE ACTUAL PRODUCT WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND ANALYZED THE DATA. THE SAVE TO DISK PRIMARY FINDING NOTED LV LEAD PACING IMPEDANCE WAS OUT OF RANGE LOW. DROP OF LV IMPEDANCE BETWEEN (B)(6) 2011 AND (B)(6)2012 TO BELOW 200 OHMS. APPEARS TO RESOLVE ITSELF AND REMAINS STABLE SINCE THEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FOR A PERIOD, THE LEFT VENTRICULAR (LV) LEAD HAD CONSIDERABLY INCREASED THRESHOLD WITH A CORRESPONDING DROP IN IMPEDANCE. THE DATA SUGGESTED A LEAD INSULATION FAILURE, BUT DURING THE MOST RECENT CHECK, EVERYTHING APPEARED STABLE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE DTB MEDTRONIC PUERTO RICO, INC. 4194

    Patients

    Seq Age Sex Outcome Treatment
    1 Other C2TR01 IMPLANTABLE PULSE GENERATOR