BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3921765 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-10968
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    December 1, 2012
    Report Date
    October 31, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    PMA / PMN Number
    P960006/S005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD EXHIBITED LOW, OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE LATEST SEND FROM THE REMOTE MONITORING SYSTEM AND DISCUSSED THAT SIGNALS ON THE ATRIAL CHANNEL MAY INDICATE POTENTIAL NOISE. FURTHERMORE, THERE APPEARED TO BE ATRIAL UNDERSENSING ON THE PRESENTING ELECTROGRAM (EGM). A REVIEW ON THE ARRHYTHMIA LOGBOOK DETERMINED THAT THERE WAS A HISTORY OF OVERSENSED NOISE ON THE ATRIAL CHANNEL; HENCE, DEVICE PROGRAMMING WAS DONE. SUBSEQUENT INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF THE OBSERVATION WAS NOT CONCLUSIVELY DETERMINED AND ADDITIONAL PROGRAMMING WILL BE PERFORMED ON THE PATIENT¿S NEXT CLINIC VISIT. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE RIGHT ATRIAL (RA) LEAD CONTINUED TO EXHIBIT OVERSENSING OF NOISE THAT WAS REPRODUCIBLE WITH ISOMETRICS. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE THE RA LEAD WAS EXPLANTED. AT THE LEAD REVISION PROCEDURE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE ALSO ELECTIVELY EXPLANTED AND THE PATIENT WAS IMPLANTED WITH A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM AS THE PHYSICIAN WANTED A MRI COMPATIBLE SYSTEM IN THE PATIENT. THERE WERE NO PERFORMANCE ALLEGATIONS AGAINST THE ICD OR RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400140 FLEXTEND IMPLANTABLE LEAD DTB BOSTON SCIENTIFIC CORPORATION 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R 0158| A135| E110| 4087