BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1852996 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-19352
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 6, 2010
    Report Date
    December 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN EXPLANTED AND RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THE LEAD WAS CAPPED/ABANDONED AND WILL NOT BE RETURNED FOR ANALYSIS. BOSTON SCIENTIFIC, CRM WILL PROVIDE ADDITIONAL INFORMATION IF IT BECOMES AVAILABLE AND AN UPDATED REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ANOTHER IMPLANT PROCEDURE HAS BEEN SCHEDULED FOR THIS PATIENT SO THAT THEY CAN RECEIVE EITHER AN ARRAY OR EPICARDIAL LEAD. NO ADDITIONAL INFORMATION IS AVAILABLE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD MAY HAVE CONTRIBUTED TO LOW, OUT-OF-RANGE SHOCK IMPEDANCE VALUES. THIS OBSERVATION WAS DISCOVERED WHILE THE PATIENT WAS HOSPITALIZED FOR OPEN HEART SURGERY AND IT WAS SUSPECTED TO HAVE OCCURRED WHEN THE LEAD WAS PINCHED/CLAMPED DURING THE SAME SURGICAL PROCEDURE. THE PHYSICIAN OPTED NOT TO CONDUCT A LOW VOLTAGE SHOCK TEST ON THE LEAD AND THE LEAD WAS SCHEDULED TO BE EXPLANTED. THE PATIENT REMAINED HOSPITALIZED DUE TO COMPLICATIONS FOLLOWING OPEN HEART SURGERY (NOT DUE TO A DEVICE ISSUE). MORE RECENTLY, WE LEARNED THAT THE PATIENT'S EJECTION FRACTION HAD IMPROVED SO MUCH THAT HER ICD MAY BE EXPLANTED IN THE NEAR FUTURE AT WHICH POINT HER LEAD(S) ALSO MAY BE EXPLANTED. HOWEVER, THE PATIENT WAS RECENTLY DISCHARGED FROM THE HOSPITAL AND WAS TOO ILL TO BE INDUCED. MORE RECENTLY, TECHNICAL SERVICES ANALYZED THE SEQUENCE OF EVENTS, THEY CONCLUDED THAT THE INITIAL ASSUMPTION - THAT THE TEMPORARY, LOW IMPEDANCE ISSUE WAS INDUCED DURING THE OPEN-HEART SURGERY WHEN THE LEAD WAS PINCHED/CLAMPED - WAS INCORRECT BECAUSE THE LOW IMPEDANCE VALUE OCCURRED 1-2 WEEKS PRIOR TO THE SURGERY. MEANWHILE, THE PATIENT WAS BROUGHT IN FOR A COMMANDED SHOCK TEST. PRIOR TO THE TEST, THE COMPETITOR'S CS LEAD WAS CAPPED AND A DF-1 PIN PLUGGED THE SVC PORT AND IMPEDANCE VALUES WERE NORMAL. FOLLOWING THE COMMANDED SHOCK TEST AT 31J, HOWEVER, A POPPING SOUND WAS HEARD AND THE LEAD WAS SUSPECTED OF HAVING A CONDUCTOR FRACTURE AND CAUSING A SHORT CIRCUIT IN THE CAN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THIS PATIENT UNDERWENT A PROCEDURE TO IMPLANT A NEW DEVICE. DURING THE PROCEDURE, THE PHYSICIAN DECIDED TO UNCAP THIS LEAD SO THAT IT COULD BE CONNECTED TO THE DEVICE TO BE IMPLANTED. HOWEVER, IT WAS DISCOVERED THAT THIS RV LEAD WAS DAMAGED APPROXIMATELY THREE INCHES FROM THE YOKE AND APPEARED TO BE KINKED. THE LEAD WAS CAPPED AGAIN AND THE PROCEDURE WAS ENDED WITHOUT A DEVICE IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 0158| 1860| 4054| 0125| 4512| 6937| 1823