BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173797 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11507
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    July 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A LEAD REVISION WAS ATTEMPTED TWO WEEKS POST DEVICE REPLACEMENT. BEFORE THE REVISION PROCEDURE, NOISE AND OVERSENSING WAS STILL OBSERVED WITH THE NEW NON-BOSTON SCIENTIFIC (BSC) DEVICE. A TEMPORARY PACING LEAD WAS INSERTED DUE TO THE PATIENT HAVING COMPLETE HEART BLOCK. FLUOROSCOPY AGAIN REVEALED CLAVICULAR/FIRST RIB ENTRAPMENT DAMAGE OF THE RV 0185 AND LV 4555 LEADS. THE RA 4087 LEAD WAS SITTING LOW IN THE RA NEAR THE TRICUSPID VALVE CLOSE TO THE RV COIL. THE POTENTIAL FOR FARFIELD NOISE ON THE RA LEAD WAS DISCUSSED. A STYLET WAS INSERTED INTO THE 0185 RV LEAD AND THE 4555 LV LEAD AND WOULD ONLY ADVANCE TO THE LOCATION OF THE CRUSH AREA. A STYLET WAS ALSO INSERTED INTO THE 4087 RA LEAD AND WOULD ONLY ADVANCE ABOUT THREE FOURTHS OF THE WAY TO THE LEAD TIP, TO APPROXIMATELY THE TOP OF THE RIGHT ATRIUM. IT WAS DETERMINED THE EXISTING RA, RV AND LV LEADS COULD NOT BE EXPLANTED BY LASER TECHNIQUE AND A NEW DEFIBRILLATION LEAD WOULD BE ATTEMPTED. OF NOTE, A STYLET WAS NOT ATTEMPTED WITH THE OLD 4088 RV LEAD. A NON-BSC RV SINGLE COIL DEFIBRILLATION LEAD WAS INSERTED WITH GREAT DIFFICULTY, A LONG SAFESHEATH WAS REQUIRED AND MULTIPLE VENOPLASTIES WERE PERFORMED TO DILATE THE VESSEL AND SUPERIOR VENA CAVA. THE LV LEAD MEASUREMENTS VIA THE PACING SYSTEM ANALYZER (PSA) MEASUREMENTS WERE UNCHANGED (LV TIP TO RING SHOWED GREATER THAN 4000 OHMS IMPEDANCE MEASUREMENTS), HOWEVER GOOD LV THRESHOLD MEASUREMENTS WERE NOTED FROM LV TIP TO RV COIL. THE NEW NON-BSC RV LEAD, AND EXISTING RA AND LV LEAD'S WERE CONNECTED TO THE NON-BSC DEVICE. THE LEADS WILL CONTINUE TO BE MONITORED CLOSELY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    A NEW DEVICE WAS IMPLANTED AND THIS LEAD REMAINS IMPLANTED. SINCE THE PROCEDURE HAD OCCURRED LATE IN THE DAY THE PHYSICIAN ELECTED TO DO THE LEAD EXTRACTION/REPLACEMENT PROCEDURE IN THE FUTURE, HOWEVER THE EXACT DATE WAS NOT GIVEN AS THE IMPLANTER WILL LIKELY BE USING ANOTHER MANUFACTURERS LEADS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION DURING A ROUTINE OFFICE VISIT THAT THIS PACEMAKER DEPENDANT PATIENT HAD SEVERAL EPISODES OF WHAT APPEAR TO BE ELECTROMAGNETIC INTERFERENCE (EMI) TWO MONTHS AGO CAPTURED VIA REMOTE MONITORING. THEY APPEAR AS NOISE ON ALL LEAD CHANNELS. ONE EPISODE DISPLAYED OVERSENSING AND RIGHT VENTRICULAR (RV) PACING INHIBITION FOR SIX SECONDS WHICH OCCURRED WHILE THE PATIENT WAS SLEEPING. DURING THE CURRENT OFFICE VISIT, THE FIELD REPRESENTATIVE WAS ABLE TO RECREATE THE NOISE AND PACING INHIBITION ON ALL CHANNELS WITH LEFT ARM ISOMETRICS. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED SUBCUTANEOUSLY AND OTHER THAN A SLIGHT DECREASE IN ALL LEAD IMPEDANCE MEASUREMENTS (WITHIN NORMAL LIMITS) ALL OTHER DIAGNOSTIC MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE PATIENT DID REPORT HAVING FALLEN IN THE PAST BUT DID NOT KNOW THE EXACT DATES. ADDITIONAL INFORMATION WAS RECEIVED THAT A REPLACEMENT PROCEDURE WAS PERFORMED ELEVEN DAYS LATER. IT WAS DISCOVERED THAT THE HEADER ON THE DEVICE WAS NOT LOOSE AND FLUOROSCOPY SHOWED POTENTIAL LEAD CLAVICULAR CRUSH ON THREE LEADS. BLOOD WAS ALSO NOTED IN THE LEAD TIPS UPON INSPECTION DURING IMPLANT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R 4087| 4088| 0185| N119| 1290| 4555| 1298