BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3052743 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05148
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE SYSTEM WAS REPLACED AT ANOTHER FACILITY. A NEW SYSTEM WAS IMPLANTED ON THE PATIENT'S RIGHT SIDE. THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS NOT AWARE OF ANY FURTHER INFORMATION. AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED. SHOULD THIS DEVICE GET RETURNED AT A LATER TIME, THIS REPORT WILL BE UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACING SYSTEM WAS ADMITTED TO THE HOSPITAL WITH SYMPTOMS OF DIZZINESS.OVERSENSING AND PACING INHIBITION WAS OBSERVED IN THE RIGHT VENTRICLE (RV) WHICH SEEMED TO CORRELATE WITH ATRIAL SENSED EVENTS. ISOMETRICS AND POCKET MANIPULATION WERE PERFORMED WHICH COULD NOT RE-CREATE THE ISSUE. THE PATIENT HAS NO UNDERLYING RHYTHM SO IS DEPENDENT ON PACING. PRIOR TESTING PERFORMED ON THE PATIENT CONFIRMED MILD ELEVATED ENZYMES AND SLIGHTLY ABNORMAL ELECTROLYTES. IT WAS NOTED THAT THE PATIENT DOESN'T COMPLAIN MUCH ABOUT SYMPTOMS, HOWEVER DOES EXHIBIT SYMPTOMS WHEN PACING THRESHOLD TESTING IS DONE. A FREE RUNNING 12-LEAD EKG WAS THEN TAKEN AND SHOWED ISOELECTRIC PREMATURE VENTRICULAR CONTRACTIONS. A LEAD CHECK CONFIRMED NORMAL DIAGNOSTICS; HOWEVER, NOISE WAS PRESENT ON BOTH CHANNELS BUT WAS NOT BEING SENSED. PATIENT TRIGGERED ELECTROGRAMS DETERMINED THE EVENTS WERE OCCURRING WHILE THE PATIENT WAS IN A SITTING OR LYING DOWN POSITION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TROUBLESHOOTING EFFORTS AND ATTEMPTS MADE TO REPROGRAM AROUND THE ISSUE WERE UNSUCCESSFUL. THE PATIENT IS BEING EVALUATED FOR A POSSIBLE RV LEAD REVISION AND PACEMAKER REPLACEMENT. A SAVE TO DISK WAS PERFORMED AND SENT TO BOSTON SCIENTIFIC ENGINEERING FOR REVIEW.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154895 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L S606| 4088| 4470