BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2780979 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12866
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 21, 2012
    Report Date
    April 9, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. VISUAL INSPECTION NOTED DEFORMED CONDUCTOR COILS ALONG WITH PUNCTURE HOLES IN THE INSULATION APPROXIMATELY 145 AND 308-311MM FROM THE TERMINAL PIN. IT WAS SUSPECTED THIS DAMAGE WAS FROM A GRABBING TOOL. 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 THIS RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENT DECREASED TO 517 OHMS FROM 1087 OHMS ONE DAY POST-IMPLANT. ADDITIONALLY, THE SENSING THRESHOLD HAD DECREASED AND THRESHOLD MEASUREMENT INCREASED. A MICRO-DISLODGEMENT WAS SUSPECTED, BUT WAS NOT VISIBLE ON THE X-RAY. THE OUTPUT WAS INCREASED AND THE PATIENT WILL BE FOLLOWED APPROPRIATELY. THE PHYSICIAN WAS ATTEMPTING TO AVOID A REVISION PROCEDURE AS THE PATIENT IS A HIGH SURGICAL RISK. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT AT THE NEXT FOLLOW-UP APPOINTMENT, THE LEAD MEASUREMENTS HAD NOT IMPROVED. AS A RESULT, THE PHYSICIAN DECIDED TO REPOSITION THE LEAD. DURING THE REPOSITIONING PROCEDURE, THE PHYSICIAN WAS NOT SATISFIED WITH THE MEASUREMENTS AND EXPLANTED THE LEAD. A COMPETITOR LEAD WAS ATTEMPTED WITH SIMILAR MEASUREMENTS. THE COMPETITOR LEAD REMAINS IMPLANTED AS THE THRESHOLD MEASUREMENT WAS SLIGHTLY LOWER. NO 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
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R