BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1791498 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-06978
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    December 7, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED IN PART ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ACTUAL LONGEVITY IS < 80% OF 99.9% LONGEVITY LIMIT. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. FURTHER ANALYSIS OF THE BATTERY FOUND NO INTERNAL SHORT IN THE BATTERY.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DETERMINED THAT THE DEVICE REACHED ERI (ELECTIVE REPLACEMENT INDICATOR) BECAUSE IT WAS PROGRAMMED TO THE HIGHEST LEFT VENTRICULAR OUTPUT. THE LEFT VENTRICULAR 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other 6949 IMPLANTABLE TACHY LEAD| ELOX COMPETITOR IMPLANTABLE PACING LEAD