BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2813026 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16719
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 DURING A ROUTINE OFFICE VISIT THAT THE PATIENT OCCASIONALLY FEELS A BURNING SENSATION. FOLLOW UP INFORMATION WAS OBTAINED FROM THE CLINIC, AND THE NURSE STATED THAT DURING THE FOLLOW UP VISIT, THE DEVICE VOLTAGE WAS INCREASED AND THE BURNING SENSATION COULD NOT BE REPLICATED. THE PATIENT WAS ADVISED TO CALL THE CLINIC IF THE BURNING SENSATION BECAME WORSE OR DID NOT GO AWAY. THE PATIENT HAS NOT CALLED THE CLINIC. IT IS UNSURE IF THE BURNING SENSATION WAS RELATED TO THE DEVICE. THE PHYSICIAN SUSPECTED A LEAD INSULATION BREAKDOWN. THE DEVICE AND LEAD REMAIN 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 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other ADSR03 IMPLANTABLE PULSE GENERATOR