BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA VR

    MDR report key: 1863149 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05079
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    October 29, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    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

    THE PATIENT REPORTED THAT SHE HAS A BURNING SENSATION BEHIND THE DEVICE. SHE ALSO REPORTED THAT THE LEAD WAS TOO THICK AND THE SUBCLAVIAN VEIN COLLAPSED AROUND THE WIRE. SHE REPORTED THAT IT FIRST HAPPENED LAST YEAR AND DUE TO THIS THE PHYSICIANS PERFORMED AN ANGIOPLASTY AND PUT HER ON COUMADIN. THIS RESOLVED THE ISSUE, BUT NOW IT HAPPENED AGAIN. SHE REPORTED THE PHYSICIAN WANTS TO DO ANOTHER ANGIOPLASTY. SHE ALSO HAS A SWOLLEN ARM. THE PATIENT FURTHER REPORTED THAT SHE FELT A SENSATION LIKE "TOUCHING A BATTERY TO YOUR TONGUE" BEHIND THE DEVICE. THE DEVICE AND LEAD ARE STILL 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 SECURA VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention