BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040775 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03252
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    October 15, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED SIX MONTHS LATER THAT THE RED ALERTS WERE STILL BEING GENERATED FOR THIS SYSTEM DUE TO SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. A BOSTON SCIENTIFIC REPRESENTATIVE CONFIRMED THAT NO ADDITIONAL TESTING WAS PERFORMED ON THIS PATIENT AND THE PHYSICIAN NOTED NO OTHER ABNORMALITIES WITH THE LEAD AND HAS CHOSEN TO MONITOR THE PATIENT WITH NO PLANNED INTERVENTION. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THERE IS MOST LIKELY AN ISSUE WITH THE DISTAL COIL ON THE ASSOCIATED LEAD AS TESTING IN ALL THREE VECTORS RESULTED IN HIGH SHOCK IMPEDANCE MEASUREMENTS. THE PATIENT WAS BROUGHT IN FOR NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING WHICH PRODUCED A SHOCK IMPEDANCE OF 144 OHMS. ADDITIONALLY, A 31J SHOCK RESULTED IN AN IMPEDANCE OF 119 OHMS. THE SYSTEM REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED STATING SHOCKING IMPEDANCE MEASUREMENTS HAVE CONTINUED TO BE ELEVATED. TESTING RECOMMENDATIONS WERE COMMUNICATED TO THIS PATIENT'S PHYSICIAN WHO HAS CHOSEN TO CONTINUE TO FOLLOW THIS PATIENT. IF THE PATIENT IS IN AGREEMENT, ALL OF THE ADDITIONAL DIAGNOSTIC TESTING WILL BE PERFORMED AT THE NEXT CLINIC VISIT. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT'S PHYSICIAN CALLED TO DISCUSS THE CONTINUED OUT OF RANGE IMPEDANCE MEASUREMENTS. THE BOSTON SCIENTIFIC PATIENT SAFETY PHYSICIAN REVIEWED THE HISTORY OF THIS LEAD AND DISCUSSED THEM WITH THIS PHYSICIAN. BOTH PHYSICIAN'S AGREED THAT IT APPEARS THERE IS SOMETHING PHYSIOLOGIC CAUSING THE IMPEDANCE RISE SUCH AS; CALCIFICATION OR ELECTROLYTE CHANGES. NON-INVASIVE PROGRAMMED STIMULATION (NIPS) AND DEFIBRILLATION TESTING (DFT) WAS PERFORMED. AT 41 JOULES, DFT TESTING WAS SUCCESSFUL AND AN IMPEDANCE MEASUREMENT OF 109 OHMS WAS RETURNED. THE LEAD WILL CONTINUE TO BE MONITORED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ELECTIVE PROCEDURE TO REPLACE THIS PATIENT'S DEVICE, SHOCK IMPEDANCE MEASUREMENTS WERE GREATER THAN 125 OHMS IN ALL THREE VECTORS. THE CALLER CONFIRMED THERE WAS NO ELECTROMAGNETIC INTERFERENCE (EMI) SOURCE NEAR THE POCKET DURING THE PROCEDURE. THE PHYSICIAN ELECTED TO USE ANOTHER DEVICE. TESTING WITH THE REPLACEMENT DEVICE PRODUCED A SHOCK IMPEDANCE OF 105 OHMS IN TRIAD CONFIGURATION; HOWEVER, SHOCK IMPEDANCE MEASUREMENTS WERE GREATER THAN 125 OHMS IN ALL OTHER CONFIGURATIONS. THE CALLER CONFIRMED THE POCKET WAS CLOSED AND WELL IRRIGATED. THE PATIENT WILL BE BROUGHT BACK IN THE NEAR FUTURE FOR NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143371 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0174

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L T135| N141| 4542| 4136