BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2060130 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05895
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, SEVERED AT 510 MM FROM THE TERMINAL PIN. THE TIP SEGMENT INCLUDING THE DISTAL COIL WAS NOT RETURNED. SET SCREW MARKS WERE NOTED ON ALL TERMINALS, ONE ON EACH. VISUAL INSPECTION FOUND THAT THE CLEAR MEDICAL ADHESIVE WAS TORN AND SEPARATED FROM THE EXPANDED-POLYTETRAFLUOROETHYLENE AT THE PROXIMAL END OF THE PROXIMAL SPRING ELECTRODE AND THE PROXIMAL SPRING WAS ALSO STRETCHED AT THIS POINT. THE DISTAL END OF THE PROXIMAL SPRING ELECTRODE IS SEPARATED FROM THE LEAD BODY INSULATION, MEDICAL ADHESIVE IS NOTED. THE RETURNED LEAD SEGMENT WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THE RETURNED POSITON OF THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. NO FURTHER TESTING WAS PERFORMED ANALYSIS COULD NOT CONFIRM THE CLINICAL ALLEGATIONS OBSERVED IN THE FIELD

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT WAS ISSUED BY THE LATITUDE HOME MONITORING SYSTEM FOR A LESS THAN 20 OHMS SHOCKING LEAD IMPEDANCE MEASUREMENT. THE PATIENT WAS BROUGHT INTO THE CLINIC INTERMITTENT IMPEDANCE MEASUREMENTS OF LESS THAN 20 OHMS WERE ABLE TO BE RECREATED WITH ISOMETRICS AND POCKET MANIPULATION. NO NOISE WAS SEEN ON THE ELECTROGRAM. THE CLINICIAN STATED THAT SHE WOULD DISCUSS RESOLUTION TO THE SITUATION WITH THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AN EMAIL WAS SENT TO THE BOSTON SCIENTIFIC SALES REPRESENTATIVE IS AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEFIBRILLATION LEAD WAS EXPLANTED TWELVE DAYS LATER DUE TO INTERMITTENT SHOCK IMPEDANCE MEASUREMENTS OF LESS THAN 20 OHMS. THE SR NOTED THAT THE PHYSICIAN WAS ONLY ABLE TO EXTRACT THE PROXIMAL COIL AND NOT THE DISTAL COIL. INSULATION DAMAGE WAS SUSPECTED, HOWEVER DAMAGE TO THE EXTRACTED PORTION WAS NOT VISABLE. IT IS UNKNOWN IF THE DISTAL COIL SECTION OF THE LEAD SUSTAINED ANY PHYSICAL DAMAGE. THE EXPLANTED PORTION OF THE LEAD WILL BE RETURNED FOR ANALYSIS.

    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 61 YR 0185| 4548| H210| 5076