BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1922804 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13082
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    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 OVERSENSING IS HAPPENING EVEN WITH THE PATIENT IS SITTING STILL. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED FROM THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A QUESTION REGARDING THE LEAD INSULATION. THERE WAS A SWITCH TO UNIPOLAR, WITH UNIPOLAR IMPEDANCE HIGHER THAN BIPOLAR IMPEDANCE OF LESS THAN 200 OHMS. THE LEAD REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERSENSING IS HAPPENING EVEN WITH THE PATIENT IS SITTING STILL. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED FROM 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| R 4568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PULSE GENERATOR| 4568 IMPLANTABLE PACING LEAD