BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1926017 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14133
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED AND BATTERY DEPLETION WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A HIGH OUTPUT, POSSIBLE EARLY BATTERY DEPLETION AND EARLY ELECTIVE REPLACEMENT INDICATOR. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR LEAD, 4193, HAD HIGH THRESHOLD. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD