BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2121975 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07828
    Event Type
    Injury
    Date Received
    June 13, 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

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS DISTORTED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DEFIB CONDUCTOR WAS DISTORTED, INNER TUBING KINKED/BUCKLED, BLOOD IN/ON HELIX/LOBE MECHANISM, AND APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    THE 5076 LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. ADDITIONAL INFORMATION OBTAINED THROUGH FOLLOW UP WITH THE PHYSICIAN OFFICE INDICATED THAT THE DEFIBRILLATION TESTING HAD FAILED. THE PATIENT WAS REFERRED FOR PLACEMENT OF A SUBCUTANEOUS LEAD. ONE WEEK LATER, THE PATIENT WAS BROUGHT IN FOR LEAD SURGERY. IT WAS ALSO NOTED THAT AT THE IMPLANT SITE, A SMALL HEMATOMA WAS SEEN.THE PHYSICIAN EVACUATED THE POCKET. FURTHER INFORMATION OBTAINED INDICATED THAT THE ATRIAL LEAD HAD DISLODGED AND NEEDED REPOSITIONING. WHILE TRYING TO REPOSITION THE LEAD, THE HELIX WOULD NOT RETRACT AND TISSUE WAS NOTED IN THE MECHANISM. THE PHYSICIAN ATTEMPTED THE LEFT SUBCLAVIAN VEIN AND THE SUBCLAVIAN ARTERY WAS PUNCTURED MULTIPLE TIMES. THE LEAD COULD NOT BE REPOSITIONED AND ANOTHER LEAD WAS USED. A NEW ATRIAL LEAD AND A NEW RIGHT VENTRICULAR (RV) LEAD WERE IMPLANTED. DEVICE REMAINS IN USE. 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 75 YR Hospitalization| L| R 4196 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6944 IMPLANTABLE TACHY LEAD