BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2790156 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14708
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 WAS SYMPTOMATIC AND FELT AS THOUGH THERE WAS A "BLOOD SUGAR PROBLEM." A TRANS-TELEPHONIC MONITORING (TTM) TRANSMISSION REVEALED LOSS OF CAPTURE ON THE LEFT VENTRICULAR (LV) LEAD AND THE PATIENT WAS INSTRUCTED TO PRESENT TO THE EMERGENCY ROOM (ER). IT WAS LATER REPORTED THAT THE LV LEAD ALSO HAD HIGH THRESHOLD. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLD, INTERMITTENT CAPTURE AND HIGH IMPEDANCE. THE LV LEAD WAS REPROGRAMMED AND REMAINS IN USE AND THE RV LEAD WAS CAPPED AND REPLACED. INFORMATION REGARDING THE SPECIFIC SYMPTOMS EXPERIENCED BY THE PATIENT AND CONFIRMATION THAT THE PATIENT DID PRESENT TO THE ER WAS ATTEMPTED TO BE OBTAINED, HOWEVER, IT WAS NOT AVAILABLE. 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. 4193

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 8042 IMPLANTABLE PULSE GENERATOR