BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3092542 · Received May 3, 2013

    Report

    Report Number
    2124215-2013-04469
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    February 6, 2013
    Report Date
    May 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP, THE SLACK OF THIS RIGHT VENTRICULAR (RV) LEAD WAS PULLED OUT, THE RV LEAD DISLODGED, AND THAT THE THRESHOLD SIGNIFICANTLY INCREASED. THE PHYSICIAN ELECTED TO REVISE THE LEAD AND INCREASE THE DEVICE'S THRESHOLD. NO LOSS OF CAPTURE OR ANY PATIENT INJURY REPORTED. AFTER THE LEAD REVISION, THE PHYSICIAN THEN DECREASED THE DEVICE'S THRESHOLD, AND NOTED THAT THE ESTIMATED BATTERY LONGEVITY HAD INCREASED FROM LESS THAN 0.5 YEARS TO 6.5 YEARS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE DEVICE WAS USING THE THRESHOLD OUTPUT THAT WAS PROGRAMMED DURING THE PROCEDURE IN MEASURING THE LONGEVITY OF THE DEVICE. WHEN THE OPERATION ENDED AND THE THRESHOLD WAS DECREASED, THE DEVICE THEN RECALCULATED THE LONGEVITY USING THE NEW PROGRAMMED VOLTAGE. TS THEN FURTHER DISCUSSED THAT THE BATTERY LONGEVITY IS EXPECTED TO DECREASE WITHIN A WEEK FROM REPROGRAMMING THE OUTPUTS AS THE DEVICE NEEDS ABOUT THAT AMOUNT OF TIME TO DO BATTERY MEASUREMENTS AND UPDATE THE LONGEVITY WITH THE NEWER OUTPUTS. AFTER A MONTH OF BATTERY MEASUREMENTS, THE ESTIMATED BATTERY LONGEVITY MEASURED WOULD BE DEEMED ACCURATE. THIS RV LEAD REMAINS IN SERVICE AND WAS REPOSITIONED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THAT DURING A ROUTINE FOLLOW-UP, THIS RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED AGAIN. THIS TIME, THE RV LEAD WAS REPLACED SUCCESSFULLY AND WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193891 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4088| 1290| 1298| 4087| K063