BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 1863083 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10641
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    July 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 HAD INTERMITTENT POCKET STIMULATION AND PAIN WHICH WAS ALSO FELT UPON DEVICE INTERROGATION. IT OCCURRED IN BOTH BIPOLAR AND UNIPOLAR WITH HIGH OUTPUTS. THE LEAD IS 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 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other E2DR01AA IMPLANTABLE PULSE GENERATOR| 4568 IMPLANTABLE PACING LEAD