BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1922136 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12763
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ARRIVED TO THE EMERGENCY DEPARTMENT (ED) WITH COMPLAINTS OF ORTHOPNEA, SHORTNESS OF BREATH, LEG EDEMA AND WEIGHT GAIN. LAB RESULTS SHOWED ELEVATED LEVELS OF BRAIN NATRIURETIC PEPTIDE (BNP), AND A CHEST X-RAY SHOWED "FEATURES OF PULMONARY CONGESTION". IT WAS ALSO REPORTED THAT AN ECHOCARDIOGRAM "SHOWED SEPTAL HYPOKINESIS WITH AN IMPAIRED LEFT VENTRICULAR DIASTOLIC FILLING, AS WELL AS MULTIPLE VALVULAR INSUFFICIENCIES". THE LEFT VENTRICULAR LEAD WAS PROGRAMMED ON, AND REMAINS IN USE. NO FURTHER 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. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 5076 (X2) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR