BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1921775 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12695
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 3, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. EVALUATION SUMMARY: (B)(4): THE FULL LEAD IN SEGMENTS WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON ALL CONDUCTORS (NOT OBSTRUCTED) INCLUDING THE DISTAL CONDUCTOR (NOT OBSTRUCTED). ALL CONDUCTORS WERE CUT, THE LEAD WAS STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE. THE OUTER INSULATION WAS MELTED, PULLED APART DUE TO OVERSTRESS, AND HAD A COSMETIC DEPRESSION. THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKS. THE ANALYST NOTED THAT THE DRIED BLOOD AND TISSUE ON THE TIP END OF THE DISTAL CONDUCTOR MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE.

    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 DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD LOSS OF CAPTURE AND DISLODGED. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4592 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB