BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2051028 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05478
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. 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. OVERSENSING WAS NOTED AS FIFTEEN VENTRICULAR NST<=210 MS AVERAGE V-CYCLE OCCURRED BETWEEN (B)(6) 2010 21:10:12 AND (B)(6) 2011 13:08:31.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN APPARENT VENTRICULAR LEAD FRACTURE AND/OR APPARENT SET SCREW PROBLEM WITH THE DEVICE. NOISE AND POSSIBLE OVERSENSING WAS NOTED ON BOTH THE ATRIAL AND VENTRICULAR LEADS. OVERSENSING IN THE FORM OF A HIGH SHORT INTERVAL COUNT WAS NOTED ON THE VENTRICULAR LEAD. THE DEVICE AND BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4592 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Other 6949 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD