BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812923 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16707
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 24, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    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. EVALUATION SUMMARY: (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD A COSMETIC CUT, THE OUTER INSULATION WAS BREACHED CUT, THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, TISSUE ON HELIX AND THERE WAS APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE HELIX DISTORTED/BENT AND TISSUE ON IT. (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION HAD A COSMETIC CUT, THE OUTER INSULATION WAS BREACHED CUT, THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, TISSUE ON HELIX, THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED. (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD A COSMETIC CUT, THE OUTER INSULATION WAS BREACHED CUT, THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE LEAD APPEARED DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS NOT CAPTURING; AN X-RAY REVEALED THAT THE ATRIAL LEAD HAD DISLODGED. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. HOWEVER, SHORTLY AFTER THE REPLACEMENT PROCEDURE, IT WAS FOUND THAT THE RIGHT VENTRICULAR [RV] LEAD AND NEWLY IMPLANTED ATRIAL LEAD WERE NOT CAPTURING; THE LEADS WERE BELIEVED TO HAVE DISLODGED WHEN THE PATIENT WAS "PULLED ONTO THE STRETCHER" BY THEIR LEFT ARM AFTER COMPLETION OF THE PROCEDURE. THE POCKET WAS RE-OPENED AND THE PHYSICIAN OPTED TO REMOVE THE RV AND ATRIAL LEADS AS THE PHYSICIAN DID NOT "LIKE THE SHAPE OF THE LEADS" AND STATED THAT BOTH LEADS "WERE ALL BENT UP." THE RV AND ATRIAL LEADS WERE 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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R VEDR01 IMPLANTABLE PULSE GENERATOR