BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 6782925 · Received August 9, 2017

    Report

    Report Number
    2182208-2017-01317
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    November 13, 2016
    Report Date
    June 30, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. UTILIZATION OF PERMANENT HIS-BUNDLE PACING FOR MANAGEMENT OF PROARRHYTHMIA RELATED TO BIVENTRICULAR PACING. PACE. 2017; 40:451¿454. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING MANAGEMENT OF PROARRHYTHMIA RELATED TO BIVENTRICULAR PACING. THE ARTICLE NOTED THE PATIENT DEVELOPED PERICARDIAL TAMPONADE POST-IMPLANT. THE PATIENT ADDITIONALLY EXPERIENCED VENTRICULAR TACHYCARDIA (VT) AND MILD HYPOTENSION REQUIRING EXTERNAL ELECTRICAL CARDIOVERSION. IT WAS NOTED THE PATIENT DEVELOPED VENTRICULAR PROARRHYTHMIA. THE DEVICE WAS REPROGRAMMED FROM BIVENTRICULAR TO MONOCHAMBER PACING. DUE TO PATIENT CONDITION, THE ARTICLE NOTED THE PATIENT RECEIVED A DEVICE UPGRADE. THE LV LEAD WAS CAPPED AND REPLACED DURING THE DEVICE UPGRADE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563516 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 4194

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R C2TR01IPG