BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3936121 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-11396
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 1, 2013
    Report Date
    April 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD RETURNED WAS SEVERED AT 16 CENTIMETERS FROM THE IS-1 TERMINAL PIN. SET SCREW MARK WAS NOTED ON ALL TERMINAL CONNECTORS, DRAG MARKS WERE ON IS-TERMINAL RING AND LEAF SPRING MARKS WERE NOTED ON IS-1 TERMINAL RING. A STYLET WAS ALSO STUCK INSIDE THE DISTAL SEGMENT AND WAS THEN EXTRACTED. THE PROXIMAL SEGMENT OF THE LEAD PASSED RESISTANCE MEASUREMENT TESTING. RESISTANCE MEASUREMENT TESTING WAS NOT PERFORMED ON THE DISTAL PORTION OF THE LEAD DUE TO A STUCK STYLET; HOWEVER, X-RAY REVEALED NO FRACTURES. THE DAMAGE WAS INDUCED IN THE FIELD, DURING EXPLANT PROCEDURE. IN CONCLUSION, THE ALLEGATION OF HIGH PACING LEAD IMPEDANCE AND HIGH PACING THRESHOLD MEASUREMENT WERE NOT CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM EXHIBITED HIGH, OUT OF RANGE, PACING IMPEDANCE AND THRESHOLDS MEASUREMENTS. THIS PATIENT LOST TO FOLLOW UP FOR TWO AND A HALF YEARS. WHEN THE PATIENT PRESENTED FOR DEVICE CHECK, DAILY MEASUREMENTS ON RV LEAD IMPEDANCE SHOWED HIGH PACING THRESHOLD AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT SINCE JUNE 2013. SHOCK LEAD IMPEDANCE MEASUREMENT WAS NORMAL AND NO NOISE WAS NOTED ON RATE- SENSE CHANNEL. POCKET MANIPULATION WAS PERFORMED TO ELICIT NOISE BUT NO NOISE WAS PRODUCED. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THIS RV LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED WITH NORMAL DIAGNOSTICS. ADDITIONAL INFORMATION WAS RECEIVED THAT A CONNECTION DEFECT WAS SUSPECTED SINCE THE X-RAY ON THE LEAD DID NOT REVEAL FRACTURE. THE LEAD WAS ALSO TESTED WITH PACING SYSTEM ANALYZER (PSA) WITH RESULTS IN NORMAL LIMITS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE WHILE THE LEAD IS NO LONGER IN SERVICE AND WAS RETURNED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413675 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R E110| 0185| 4470