BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2130740 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10227
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. ANALYSIS OF THE 4194 LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM.

    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 DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM. (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE STYLET COULD NOT BE INSERTED INTO THE LEAD DURING REPOSITIONING. THIS LEAD WAS REMOVED AND REPLACED WITH ANOTHER LEAD. ADDITIONALLY, A LEFT VENTRICULAR LEAD WAS ATTEMPTED BUT DID NOT REACH THE DESIRED LOCATION AND WAS REPLACED WITH ANOTHER LEAD. OVERSENSING WAS NOTED ON THE DEVICE. THE SENSITIVITY WAS LOWERED AND THE PROBLEM RESOLVED UNTIL THE TECHNICIAN WAS HOLDING PRESSURE ON THE DEVICE POCKET AND OVERSENSING STARTED AGAIN. THE PHYSICIAN OPENED THE POCKET, DISCONNECTED ALL LEADS, AND REPLACED THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE SENSITIVITY WAS LOWERED AND THE PROBLEM RESOLVED UNTIL THE TECHNICIAN WAS HOLDING PRESSURE AND THE RV LEAD STARTED OVERSENSING AGAIN. THE PHYSICIAN OPENED THE POCKET AND DISCONNECTED ALL LEADS. THE RV LEAD CHECKED OUT FINE THROUGH THE ANALYZER BUT WHEN IT WAS RECONNECTED TO THE DEVICE THE OVERSENSING WAS NOTED AGAIN. THE ENTIRE SYSTEM WAS 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 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O| R