BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2060074 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-06353
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 31, 2011
    Report Date
    June 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE COMPLETE LEAD WAS RETURNED. VISUAL INSPECTION NOTED THAT SUTURE FOOTPRINTS SHOWED THAT THE SUTURE SLEEVE WAS TIED-DOWN AT 190 TO 210 MM FROM THE IS-1 PIN. THE RATE SENSE (RS) COILS WERE FRACTURED AT 215 MM FROM THE TERMINAL PIN AND THERE WAS A NOTICEABLE BEND IN THE LEAD ABOVE THE RS-COIL FRACTURE SITE. THE TRI-LUMEN INSULATION IN THE AREA OF THE FRACTURE WAS NOT DAMAGED, WHICH THE LABORATORY TECHNICIAN STATED MAY SUGGEST THAT THE FRACTURE WAS NOT DUE TO CLAVICLE FIRST RIB CRUSH, BUT WAS POSSIBLY DUE TO A BEND AT THE DISTAL END OF SUTURE SLEEVE TIE-DOWN. A CLAVICLE CRUSH NORMALLY RUPTURES AND PUNCTURES THE INSULATION IN A WAY THAT RESEMBLES A ZIPPER-LIKE OR JAGGED-EDGE, THIS WAS NOT OBSERVED AT THE FRACTURE SITE. THE LEAD WAS SENT FOR FURTHER DETAILED ANALYSIS. AN X-RAY OF THE LEAD REVEALED THAT THE RS FRACTURE WAS LOCATED BETWEEN 215 AND 234 MM FROM THE TERMINAL PIN WITH A SECONDARY FRACTURE ON WIRE ONE ON THE DISTAL SIDE. DEFORMATION ON THE INNER INSULATION BETWEEN THE TWO FRACTURED ENDS OF THE RS-COIL WAS ALSO OBSERVED. THE FRACTURE SURFACES OF WIRES OF THE RS-COIL DID REVEAL SOME EVIDENCE OF FATIGUE WITH MOST ALSO SHOWING EVIDENCE OF OVERLOAD. ANALYSIS CONFIRMED THE FIELD ALLEGATION OF A FRACTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT WAS GENERATED BY THE LATITUDE HOME MONITORING SYSTEM FOR HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. TWO DAYS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WHERE NOISE ON THE DEFIBRILLATION LEAD LED TO DELIVERY OF INAPPROPRIATE TACHYCARDIA THERAPY. A LEAD REVISION PROCEDURE WAS SCHEDULED. UPON REMOVAL OF THE LEAD, A FRACTURE DUE TO CLAVICULAR CRUSH WAS OBSERVED. A NEW LEAD WAS IMPLANTED AND WAS NOTED TO EXHIBIT GOOD IMPEDANCE MEASUREMENTS THROUGH THE PACING SYSTEM ANALYZER, SO THE POCKET WAS CLOSED. UPON POCKET CLOSURE, FURTHER TESTING SHOWED IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS. IT WAS NOTED THAT WHEN THE PHYSICIAN INSERTED THE NEW DEFIBRILLATION LEAD INTO THE DEVICE HEADER, HE EXPERIENCED DIFFICULTY TIGHTENING THE SET SCREWS ON THE DEVICE. THE POCKET WAS REOPENED AND THE SETSCREWS MADE A RATCHETING SOUND. THE NEWLY IMPLANTED DEFIBRILLATION LEAD WAS ABLE TO BE REMOVED WITHOUT INCIDENT, HOWEVER THE SET SCREWS ON THE DEVICE HEADER CONTINUED TO MAKE A RATCHETING SOUND. VISUAL INSPECTION OF THE LEAD REVEALED THAT THE GORE COATING ON THE SVC ELECTRODE WAS BUNCHED UP AND SEEMED TO HAVE PULLED AWAY FROM THE COIL. THE DEVICE AND DEFIBRILLATION LEAD WERE EXPLANTED AND A NEW DEVICE AND ANOTHER NEW DEFIBRILLATION LEAD WERE SUCCESSFULLY IMPLANTED IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE LEAD REVISION PROCEDURES.

    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 63 YR Hospitalization| L| R 4543| 0185| 4136| H220