BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2090438 · Received May 16, 2011

    Report

    Report Number
    2649622-2011-07552
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    September 19, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED 18JUN2012: :IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR LEAD ((B)(4)) HAD INCREASED IMPEDANCE AND FAILURE TO CAPTURE. EVENTUALLY THE PATIENT WAS NOT FEELING WELL AND THE LEAD WAS EXPLANTED AND REPLACED. THE PHYSICIAN NOTED THAT THE LEAD APPEARED BROKEN NEAR THE POCKET AND WAS EASILY REMOVED. THE LEAD HAS BEEN RETURNED. 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.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND ALL CONDUCTORS WERE FRACTURED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE INNER INSULATION WAS KINKED/BUCKLED, THE INNER TUBING WAS KINKED/BUCKLED, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THE LEAD WAS STRETCHED. ADDITIONAL INFORMATION RECEIVED (B)(4) 2012: IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR LEAD ((B)(4)) HAD INCREASED IMPEDANCE AND FAILURE TO CAPTURE. EVENTUALLY THE PATIENT WAS NOT FEELING WELL AND THE LEAD WAS EXPLANTED AND REPLACED. THE PHYSICIAN NOTED THAT THE LEAD APPEARED BROKEN NEAR THE POCKET AND WAS EASILY REMOVED. THE LEAD HAS BEEN RETURNED. 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 THE PATIENT DEVELOPED A RIGHT PNEUMOTHORAX AFTER IMPLANT OF THE PACEMAKER AND TWO LEADS. A CHEST TUBE WAS PLACED AND THE PNEUMOTHORAX RESOLVED THE NEXT DAY. ON THE SECOND DAY POST OP THE PATIENT CONTINUED TO HAVE CHEST PAIN, A CHEST X-RAY REVEALED THE VENTRICULAR LEAD HAD MOVED. IN ADDITION THERE HAD BEEN MULTIPLE EPISODES OF FAILURE TO CAPTURE. THE PATIENT UNDERWENT A LEAD REVISION AND WAS DISCHARGED TO HOME THE NEXT DAY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A RIGHT PNEUMOTHORAX AFTER IMPLANT OF THE PACEMAKER AND TWO LEADS. A CHEST TUBE WAS PLACED AND THE PNEUMOTHORAX RESOLVED THE NEXT DAY. ON THE SECOND DAY POST OP THE PATIENT CONTINUED TO HAVE CHEST PAIN, A CHEST X-RAY REVEALED THE VENTRICULAR LEAD HAD MOVED. IN ADDITION THERE HAD BEEN MULTIPLE EPISODES OF FAILURE TO CAPTURE. THE PATIENT UNDERWENT A LEAD REVISION AND WAS DISCHARGED TO HOME THE NEXT DAY. NO FURTHER 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 12 YR Hospitalization| L| R