BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2053491 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05910
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY - (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. CALCULATIONS BASED ON IMPLANT PARAMETERS INDICATE THAT THE DEVICE HAD MET ITS 99.9% EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. THIS DEVICE IS PART OF THE FIELD ACTION AND HAS TESTED CONSISTENT WITH THE FIELD ACTION. (B)(4) - THE FULL LEAD WAS RETURNED IN SEGMENTS AND NO ANOMALIES WERE FOUND. HOWEVER, ALL CONDUCTORS WERE STRETCHED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THE LEAD WAS STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FAR FIELD P-WAVE SENSING ON THE VENTRICULAR LEAD. FURTHER INFORMATION REVEALED THAT EVERYTHING WAS NORMAL WITH THE SYSTEM BUT THERE MAY HAVE BEEN A TRANSMISSION ISSUE WITH THE DEVICE. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VENTRICULAR LEAD FRACTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FAR FIELD P-WAVE SENSING ON THE VENTRICULAR LEAD. FURTHER INFORMATION REVEALED THAT EVERYTHING WAS NORMAL WITH THE SYSTEM BUT THERE MAY HAVE BEEN A TRANSMISSION ISSUE WITH THE DEVICE. THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR AND WAS EXPLANTED AND REPLACED. THE LEAD WAS ALSO EXPLANTED AND REPLACED. NO 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 NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO, INC. 5092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other 5524M IMPLANTABLE PACING LEAD| 3058 URINARY IMPLANTABLE PULSE GENERATOR| 3889 URINARY LEAD| 5524M IMPLANTABLE PACING LEAD| 3889 URINARY LEAD