BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2052885 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04178
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 1, 2011
    Report Date
    February 24, 2011
    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 PATIENT WILL BE SEEN AGAIN TO FURTHER EVALUATE THE CRT-D AND RV LEAD. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED 32 NONSUSTAINED EPISODES DUE TO NOISE OVERSENSING. NO INAPPROPRIATE SHOCKS WERE DELIVERED. THE NOISE WAS VERY SMALL IN AMPLITUDE AND ON THE RIGHT VENTRICULAR (RV) LEAD ONLY. THE ELECTROGRAMS REVEALED THAT THE NOISE RESULTED IN PACING INHIBITION FOR 2 TO 3 SECONDS. THE PATIENT REPORTED FEELING LIGHTHEADED DURING THESE EPISODES. THIS PATIENT IS PACE-MAKER DEPENDENT. THE SOURCE OF THE NOISE IS UNKNOWN AND THE PATIENT IS NOT IN CONTACT WITH ANY MAGNETIC FIELDS OR MACHINES OTHER THAN COMPUTERS. HOWEVER, THIS PATIENT DOES USE AN OLD ELECTRIC BLANKET. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening S603| 4087| 4086