BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2050550 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04512
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    November 3, 2010
    Report Date
    May 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS EVENT CONTINUES AS A REQUEST FOR ADDITIONAL INFORMATION WAS MADE TO THE FIELD. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS AVAILABLE FROM THE FIELD. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT CONTACTED BOSTON SCIENTIFIC'S WARRANTY DEPARTMENT IN (B)(6) 2011 TO REPORT THAT THE IMPLANTED DEVICE AND LEAD SYSTEM HAD MALFUNCTIONED. THE PATIENT INFORMED TECHNICAL SERVICES THAT THE DEVICE WAS EXPLANTED IN (B)(6) 2010 AND REPLACED WITH A COMPETITOR DEVICE. AS A RESULT OF THIS UNSCHEDULED REPLACEMENT, THE PATIENT EXPERIENCED PAIN AND SUFFERING. THE CONSULTANT EXPLAINED THE WARRANTY GUIDELINES AND WAS INFORMED THAT THE PATIENT PLANS TO SEEK LEGAL CONSULTATION.

    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 63 YR MISMATCH| 4086| 4087| 1291