BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4883197 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-05965
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    April 27, 2015
    Report Date
    May 29, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL OBSERVATION CONFIRMED THAT THE LEAD WAS RETURNED IN TWO SEVERED PORTIONS. THERE WERE SETSCREW MARKINGS NOTED ON THE TERMINALS. CUTS WERE NOTED IN THE LEAD INSULATION AT THE SUTURE SLEEVE TIE DOWN LOCATION. THE CONDUCTOR COILS WERE STRETCHED IN THE MID BODY PORTION OF THE RETURNED PORTION. ADDITIONALLY, THE DISTAL END OF THE PROXIMAL SPRING, WITH THE PROXIMAL END OF THE DISTAL SPRING, WERE FOUND SEPARATED FROM THE LEAD BODY, AND THERE WAS MEDICAL ADHESIVE PRESENT. THE LEAD INSULATION WAS CUT AROUND THE TIP, WHICH IS LIKELY FROM THE LASER EXTRACTION PROCESS AND PULLING ON THE LEAD. THE MESH TIP AND TIP TINES WERE NEVER RETURNED. THIS DAMAGE WAS DETERMINED TO BE PROCEDURALLY INDUCED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED THRESHOLDS AS WELL AS HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCES OF GREATER THAN 2000 OHMS. THE PHYSICIAN BELIEVES THE LEAD WAS FRACTURED IN THE CLAVICLE REGION. THE LEAD WAS LASER EXTRACTED AND REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426285 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 4136| 0175| E110