BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1851870 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14388
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 12, 2010
    Report Date
    August 10, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED SETSCREW MARKS ON ALL TERMINAL CONNECTORS. THE SUTURE SLEEVE MOVED FREELY ON THE LEAD BODY. THERE WERE NO OBVIOUS SIGNS OF A SUTURE FOOTPRINT ON THE SUTURE SLEEVE. THE RATE/SENSE (RS) COILS WERE SLIGHTLY KINKED AT A POINT 32 CENTIMETERS (CM) FROM THE IS-1 TERMINAL PIN. THE POLYTETRAFLUOROETHYLENE (PTFE) LAYER OF THE LEAD BODY WAS BUNCHED UP AND THE RS COILS WERE RIPPLED SPORADICALLY IN AN AREA 27-46 CM FROM THE IS-1 PIN; THE LEAD BODY ALSO WAS SLIGHTLY TWISTED IN THESE REGIONS. THE STYLET INSERTION TEST FAILED AT 47 CM FROM THE IS-1 PIN, MOST LIKELY DUE TO A COMBINATION OF THE TWISTED LEAD BODY, THE PTFE BUNCHING, AND THE RIPPLED RS- COIL. THE HELIX MECHANISM TEST FAILED, MOST LIKELY DUE TO DRIED BLOOD IN THE MECHANISM AND/OR THE COMBINATION OF THE PREVIOUSLY NOTED DEFORMATION IN THE LEAD BODY. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE LEAD IS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISLODGED AND WAS SUBSEQUENTLY EXPLANTED AND REPLACED. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED AN ATTEMPT WAS MADE TO REPOSITION THIS LEAD, BUT UNSUCCESSFUL DUE TO SCAR TISSUE AND THE LEAD'S PROXIMITY TO THE CLAVICLE. THE PHYSICIAN NOTED THAT THE SUTURE SLEEVE WAS NOT SECURED IN THE POCKET, AS THE SUTURE APPEARED TO HAVE SLIPPED OFF THE SLEEVE. THE PHYSICIAN ALSO REPORTED UNSPECIFIED DAMAGE TO THE LEAD DURING THE REPOSITIONING ATTEMPTS. THERE WERE NO ADVERSE PATIENT EFFECTS, AND LEAD RETURN FOR ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0138

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 4136| N119| 4542| 0138