BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2131082 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10379
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. LOW RESISTANCE/IMPEDANCE OF 24 OHMS RECORDED.

    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

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE CLINIC AFTER EXPERIENCING TACHYCARDIA AFTER LEANING AGAINST A LARGE SPEAKER SYSTEM. IT WAS NOTED THAT THE DEVICE HAD SWITCHED THE PACING POLARITY OF THE LEFT VENTRICULAR LEAD (B)(6) PREVIOUSLY. IT WAS ALSO REPORTED THAT THERE WAS A RECENT LEAD WARNING ON THE RIGHT VENTRICULAR LEAD DUE TO LOW IMPEDANCE. THE DEVICE AND RIGHT VENTRICULAR LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 1699 COMPETITOR IMPLANTABLE PACING LEAD| 4548 COMPETITOR IMPLANTABLE PACING LEAD| 4548 COMPETITOR IMPLANTABLE PACING LEAD| 1699 COMPETITOR IMPLANTABLE PACING LEAD