BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE

    MDR report key: 6009219 · Received October 6, 2016

    Report

    Report Number
    2649622-2016-13316
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    August 22, 2016
    Report Date
    August 22, 2016
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: D274DRG ICD, IMPLANTED (B)(6) 2011. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD HAD FRACTURED. THIS PORTION OF THE LEAD WAS CAPPED AND REPLACED WHILE THE DEFIBRILLATION COILS REMAINED IN USE. THE LEAD WAS LATER REMOVED AS PART OF A SYSTEM DOWNGRADE FROM DUAL TO SINGLE CHAMBER DEFIBRILLATOR WHEN THE DEVICE HAD REACHED END OF LIFE (EOL). THE PROXIMAL ENDS OF THE LEAD WERE CUT. MULTIPLE ATTEMPTS WERE MADE TO BACK OUT THE HELIX BUT IT COULD NOT BE WITHDRAWN. A LASER SHEATH WAS THEN DIRECTED OVER THE RV LEAD BUT THE PHYSICIAN WAS NOT ABLE TO ENTER THE SUBCLAVICULAR REGION DUE TO SCAR TISSUE AND BINDING OF THE LEADS. REMOVAL OF THE RIGHT ATRIAL (RA) LEAD WAS THEN ADDRESSED. THE LEAD HAD BEEN FOUND TO BE NON-FUNCTIONAL AS NO ELECTRICAL ACTIVITY WAS NOTED ON THE LEAD AND IT WAS NOT CAPTURING. A LASER SHEATH WAS THEN DIRECTED OVER THE RA LEAD AND AGAIN COULD NOT BE PASSED BEYOND THE SUBCLAVICULAR REGION DUE TO SCAR TISSUE, CALCIFICATION AND BINDING OF THE LEADS. A ROTATIONAL SHEATH WAS THEN PLACED OVER THE RV AND RA LEADS WHICH WAS ABL E TO ENTER THE SUBCLAVICULAR REGION WITH GENTLE MANIPULATION. AFTER THE SUBCLAVICULAR AREA WAS CLEARED WITH THE ROTATIONAL SHEATH, THE LASER SHEATHS WERE REAPPLIED AND THE LEADS WERE ABLE TO BE RELEASED. THE RV PACING LEAD, WHICH HAD EARLIER REPLACED THE PACE/SENSE PORTION OF THE RV DEFIBRILLATION LEAD, UNRAVELED DURING THE LEAD EXTRACTION AND BROKE WITHIN THE INNOMINATE VEIN, LEAVING THE DISTAL PORTION ATTACHED TO THE RIGHT VENTRICULAR SEPTAL WALL. ALL COMPONENTS OF THE RV DEFIBRILLATION AND RA LEAD WERE THEN REMOVED. A VENOGRAM WAS PERFORMED DURING WHICH DENSE COLLATERAL VEINS WERE SEEN SURROUNDING THE OCCLUDED SUBCLAVICULAR REGION. ATTENTION WAS THEN TURNED TO SNARING THE REMAINING RV PACING LEAD. THE LEAD WAS GENTLY PULLED DOWN THROUGH THE INFERIOR VENA CAVA AND ULTIMATELY REMOVED VIA THE RIGHT FEMORAL VEIN. AT THIS POINT, ALL PRODUCTS HAD BEEN REMOVED FROM THE VASCULATURE. A NEW RV DEFIBRILLATION LEAD WAS THEN IMPLANTED. THE PATIENT DID NOT RECEIVE A NEW RA LEAD AS THE ATRIUM WAS ELECTRICALLY INACTIVE AND UNEXCITABLE AFTER CONSIDERABLE MAPPING AND STIMULATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654592 SELECTSECURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R 6949 LEAD, 5076 LEAD