BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2130998 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10341
    Event Type
    Injury
    Date Received
    June 16, 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 6949 LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THE DEFIBRILLATION AND DISTAL CONDUCTORS WERE DISTORTED AND THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY. THE OUTER TUBING OVERLAY WAS ALSO KINKED/BUCKLED, MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, AND A BREACHED CUT. THERE WAS A COSMETIC DEPRESSION ON THE OUTER INSULATION ALSO. THERE WAS BLOOD IN/ON THE HELIX MECHANISM, A DEFORMATION/FRACTURE IN THE PROXIMAL SECTION OF THE INNER COIL, INDICATING EXTENSION PROBLEMS, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE DEVICE CHANGE OUT DUE TO ELECTIVE REPLACEMENT INDICATORS (ERI), AND DURING THE DFT TESTING, THE PATIENT COULD NOT BE SUCCESSFULLY DEFIBRILLATED AND HAD TO BE RESCUED EXTERNALLY. SURGERY WAS DELAYED DUE TO THE PHYSICIAN DECIDING ON ACTION PLAN. NINE DAYS LATER, DURING THE NEW PROCEDURE, THE PHYSICIAN DECIDED TO TRY A NEW RIGHT VENTRICULAR (RV) LEAD IN CASE THE 6949 LEAD HAD FRACTURED. UPON TRYING TO EXTRACT THE 6949, THE PHYSICIAN UNINTENTIONALLY PULLED THE ENTIRE SYSTEM OUT. AFTER PLACING AN ENTIRELY NEW SYSTEM, THE PATIENT STILL COULD NOT BE DEFIBRILLATED DURING DFT TESTING. THEREFORE, THE PHYSICIAN DECIDED TO ADD ANOTHER CS TRANSVENOUS LEAD. THIS WAS SUCCESSFUL AND THE CASE WAS FINISHED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE DEVICE CHANGE OUT DUE TO ELECTIVE REPLACEMENT INDICATORS (ERI), ANDDURING THE DFT TESTING, THE PATIENT COULD NOT BE SUCCESSFULLY DEFIBRILLATED AND HAD TO BE RESCUED EXTERNALLY. SURGERY WAS DELAYED DUE TO THE PHYSICIAN DECIDING ON ACTION PLAN. NINE DAYS LATER, DURING THE NEW PROCEDURE, THE PHYSICIAN DECIDED TO TRY A NEW RIGHT VENTRICULAR (RV) LEAD IN CASE THE 6949 LEAD HAD FRACTURED. UPON TRYING TO EXTRACT THE 6949, THE PHYSICIAN UNINTENTIONALLY PULLED THE ENTIRE SYSTEM OUT. AFTER PLACING AN ENTIRELY NEW SYSTEM, THE PATIENT STILL COULD NOT BE DEFIBRILLATED DURING DFT TESTING. THEREFORE, THE PHYSICIAN DECIDED TO ADD ANOTHER CS TRANSVENOUS LEAD. THIS WAS SUCCESSFUL AND THE CASE WAS FINISHED. NO FURTHER PATIENT COMPLICATIONS WERE 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 78 YR Hospitalization| L| R B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB