BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2162623 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07092
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    March 3, 2011
    Report Date
    July 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED A REVISION PROCEDURE TOOK PLACE. THE RV LEAD WAS EXPLANTED DUE TO THE SUSPECTED CONDUCTOR FRACTURE. THERE WERE DIFFICULTIES REPORTED WITH THE HELIX MECHANISM DURING THE EXTRACTION OF THE RV LEAD. THE DEVICE WAS ALSO ELECTIVELY REPLACED ALTHOUGH NORMAL FUNCTION WAS REPORTED. AT THIS TIME THE LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. ANALYSIS CONFIRMED THAT THE LEAD WAS FRACTURED IN MULTIPLE PLACES BETWEEN 251.0 AND 266.3 MM FROM THE TERMINAL PIN. SIX FRACTURES RESULTING IN TWELVE INDIVIDUAL FRACTURE SURFACES WERE OBSERVED ON THE RS- COIL. SPOTS COMPOSED PRIMARILY OF CALCIUM AND PHOSPHOROUS WERE OBSERVED ON THE SURFACE OF THE OUTER INSULATION IN THE REGION OF THE FRACTURE. ALL OF THE FRACTURE SURFACES WERE OBSCURED BY MECHANICAL DAMAGE, BUT MOST RETAINED SOME EVIDENCE OF FATIGUE. TWO INCLUSIONS WERE NOTED, EACH COMPOSED OF PRIMARILY TITANIUM. THE INCLUSIONS ARE LIKELY TITANIUM CARBO-NITRIDES FROM THE MANUFACTURING PROCESS. IT IS KNOWN A FRACTURED LEAD COULD LEAD TO NOISE AND INAPPROPRIATE SHOCKS TO BE DELIVERED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS SUSPECTED TO HAVE A CONDUCTOR FRACTURE. THERE WAS PREVIOUS EPISODES OF NOISE NOTED, HOWEVER THE CLINIC DISMISSED THE NOISE AS ELECTROMAGNETIC INTERFERENCE (EMI) BECAUSE THE PATIENT HAD REPORTEDLY BEEN WORKING NEAR AN ENGINE. APPROXIMATELY ONE MONTH LATER THE PATIENT RECEIVED TWO INAPPROPRIATE SHOCKS FROM TWO DIFFERENT EPISODES THAT OCCURRED THREE DAYS APART. A LEAD REVISION PROCEDURE PLANNED TO BE SCHEDULED. IT WAS ALSO REPORTED THAT PATIENT HAD A HISTORY OF LEAD FRACTURES WHICH WAS POSSIBLY RELATED TO THE PATIENT'S USE OF CRUTCHES 100% OF THE TIME.

    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 50 YR Life Threatening| R T175| 0185