BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151353 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06302
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    March 30, 2011
    Report Date
    May 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION FOUND THAT THE OUTER INSULATION WAS BUNCHED BETWEEN 11 TO 21 CENTIMETERS FROM THE LEAD'S TERMINAL PIN. THE INSULATION FOR THE RATE/SENSE CONDUCTOR COIL WAS ALSO FOUND TO BE WRINKLED BETWEEN 22 TO 31 CENTIMETERS FROM THE TERMINAL PIN AS WELL. INSPECTION ALSO NOTED SEPARATION OF THE GORE' COVERING FROM THE MEDICAL ADHESIVE (MA) OF BOTH THE PROXIMAL AND DISTAL SHOCKING COILS. THE LEAD BODY WAS FOUND TO BE TWISTED AND THE HELIX WAS STRETCHED WITH TISSUE ENTWINED AROUND THE BASE. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO CONFIRM THE CHANGES IN ELECTRICAL MEASUREMENTS AND THE LEAD DISLODGEMENT. HOWEVER, ANALYSIS DID OBSERVE DAMAGE TO THE LEAD BODY AND HELIX INDICATIVE OF TWIDDLER'S SYNDROME.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD WAS WOKEN UP AFTER RECEIVING A SHOCK. INTERROGATION OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOUND THAT THE SHOCK WAS APPROPRIATE DUE TO A VENTRICULAR TACHYCARDIA. HOWEVER, IT WAS ALSO DISCOVERED THAT THIS RA LEAD WAS NOT FUNCTIONAL AND BELIEVED TO HAVE DISLODGED. THIS INFORMATION HAD BEEN COMMUNICATED TO THE PHYSICIAN IN (B)(6) 2010 BUT NOT ACTION WAS TAKEN AT THE TIME. IN ADDITION, THE RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH AN INCREASE IN PACING IMPEDANCE MEASUREMENTS FROM 485 TO 1,400 OHMS AND AN INCREASE IN PACING THRESHOLDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A REVISION PERFORMED TO EVALUATE THE LEADS. BOTH THE RV AND RA LEADS WERE FOUND TO BE VERY TWISTED IN THE POCKET REGION. THE RA LEAD WAS FULLY RETRACTED INTO THE POCKET. AN X-RAY WAS PERFORMED AND REVEALED THAT THE RV LEAD TIP WAS IN THE CORRECT POSITION BUT THE HELIX HAD MOSTLY RETRACTED WHICH WOULD ACCOUNT FOR THE CHANGES IN LEAD PACING IMPEDANCES AND THRESHOLDS. WHEN QUESTIONED, THE PATIENT DENIED TWIDDLING THE DEVICE. THE PHYSICIAN NOTED THAT THE POCKET WAS LARGER THAN THE ACTUAL DEVICE AND SUSPECTS THAT THE ICD MAY HAVE TWISTED WHILE IMPLANTED. THE RA LEAD WAS EXPLANTED WHERE IT WAS DISCOVERED THAT THE HELIX WAS EXTENDED BUT VERY BENT. ATTEMPTS TO RE-INSERT A STYLET INTO THE RV LEAD WERE UNSUCCESSFUL AND IT WAS ALSO NOTED THAT THE LEAD BODY WAS KINKED. THE RV LEAD WAS ALSO EXPLANTED. BOTH LEADS WERE SUCCESSFULLY REPLACED AND CONNECTED TO THE ICD WITH NORMAL MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED IN ASSOCIATION WITH THIS SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    THE LEAD WAS LATER RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention