BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK SQ

    MDR report key: 2173832 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10795
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 27, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P910077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RV LEAD WAS REPAIRED AND REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE SQ ARRAY WAS REPAIRED AND REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. THE DEVICE WAS REPROGRAMMED TO AVOID THIS ISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FURTHER AMENDED REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE RV LEAD AND DEVICE REMAIN IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMEDED REPORT SUBMITED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS SUB-Q ARRAY LEAD REPORTED HEARING BEEPING TONES COMING FROM THE DEVICE EVERY SIX HOURS. THE BEEPING TONES WERE ALSO IDENTIFIED DURING MAGNET APPLICATION BY THE PATIENT. A DATA DISK REVIEWED BY BOSTON SCIENTIFIC ENGINEER WHICH CONFIRMED LOW SHOCKING IMPEDANCE VALUES OF LESS THAN 20 OHMS. THE REASON FOR THE BEEPING TONES WAS LIKELY DUE TO A SHORTED LEAD CONDITION WHICH COULD LEAD TO INTERNAL CIRCUITRY DAMAGE TO THE DEVICE AND THUS PREVENT THE DEVICE FROM EFFECTIVELY DELIVERING SHOCK THERAPY. NO ADVERSE PATIENT EFFECTS REPORTED. SUBSEQUENT INFORMATION WAS RECEIVED: DURING A FOLLOW-UP VISIT, NOISE WAS NOTED ON THE SHOCK CHANNEL DURING PATIENT MANEUVERS. A CHEST X-RAY REVEALED THAT ONE PART OF THIS LEAD WAS FRACTURED OR STRETCHED, HOWEVER WOULD NOT IMPACT LEAD FUNCTION. A DECISION REGARDING LEAD REVISION OR DEVICE REPLACEMENT TO PROGRAM AROUND THIS LEAD CONFIGURATION WILL BE MADE IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    FURTHER INVESTIGATION OF THIS PRODUCT ISSUE REVEALED THAT DURING THE DEVICE TESTING WITH THE PATIENT IN (B)(6) 2011, ELECTROGRAM ANALYSIS WAS PERFORMED WHILE THE PATIENT WAS PERFORMING A PALM PRESS AND MOVEMENTS WITH SHOULDERS AND ARMS; NOISE WAS PRESENT DURING THE MOVEMENTS ON THE SHOCK CHANNEL ONLY, THE RIGHT VENTRICULAR PACE/SENSE CHANNEL WAS FREE OF NOISE. A CHEST X-RAY WAS PERFORMED TO EVALUATE THE LEAD COIL POSITION AND LEAD CONDITION. THE X-RAY REVEALED THAT ONE OF THE THREE FINGERS OF THE SQ ARRAY WAS DAMAGED WHICH WAS SUSPECTED TO BE CAUSE FOR THE LOW SHOCK IMPEDANCE. AS THE DAMAGE OF THE SQ ARRAY WAS LOCATED ON THE METALLIC PORTION OF THE FINGER, IT DID NOT AFFECT THE SQ ARRAY FUNCTION. A REVISION PROCEDURE WAS PERFORMED AND A NEW DEVICE WAS IMPLANTED WITH THE POSSIBILITY TO REPROGRAM THE SHOCK VECTOR AND TO HAVE A HIGHER SHOCK IMPEDANCE. A HORIZONTAL SQ CONFIGURATION WAS SELECTED AS THIS MADE FOR A BETTER SHOCKING FIELD OVER THE HEART. THE DAMAGE TO THE SQ ARRAY WAS REPAIRED WITH A LEAD REPAIR KIT. NO DAMAGE TO THE RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS CONFIRMED AND THE LEAD REMAINED IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD, AND SUB-Q ARRAY LEAD REPORTED HEARING BEEPING TONES COMING FROM THE DEVICE EVERY SIX HOURS. THE BEEPING TONES WERE ALSO IDENTIFIED DURING MAGNET APPLICATION BY THE PATIENT. A DATA DISK WAS SENT INTO A BOSTON SCIENTIFIC ENGINEER FOR REVIEW. AFTER REVIEW, THE ENGINEER'S ANALYSIS CONFIRMED LOW SHOCKING IMPEDANCE VALUES OF LESS THAN 20 OHMS. THE REASON FOR THE BEEPING TONES WAS LIKELY DUE TO A SHORTED LEAD CONDITION WHICH COULD LEAD TO INTERNAL CIRCUITRY DAMAGE TO THE DEVICE AND THUS PREVENT THE DEVICE FROM EFFECTIVELY DELIVERING SHOCK THERAPY. NO ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD AND DEVICE REMAIN IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY 5 MONTHS LATER, THE DECISION WAS MADE TO REMOVE AND REPLACE THE DEVICE DUE TO THE MANY SHOCKING VECTORS THAT COULD BE THE CAUSE FOR THE LOW SHOCK IMPEDANCE. WITH A NEW DEVICE IT WAS FELT THERE WOULD BE THE POSSIBILITY TO REPROGRAM THE SHOCK VECTOR AND TO HAVE A HIGHER SHOCK IMPEDANCE. THE DEVICE WAS REMOVED AND REPLACED AND A HORIZONTAL SQ CONFIGURATION WAS SELECTED AS THIS MADE FOR A BETTER SHOCKING FIELD OVER THE HEART (THE PROXIMAL COIL WAS A LITTLE OUTSIDE OF THE HEART) AND THE FACT THAT DURING PREPARATION OF THE ELECTRODES, THE INSULATION OF THE PROXIMAL SHOCK COIL WAS DAMAGED AND REPAIRED WITH A LEAD REPAIR KIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK SQ IMPLANTABLE LEAD DTB CPI - DEL CARIBE 0085

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R