BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 3052570 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04516
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVZ
    PMA / PMN Number
    P840068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROGRAMMING CHANGES WERE ATTEMPTED, HOWEVER, DID NOT RESOLVE THE NOISE AND OVERSENSING. THE LOCAL FIELD REPRESENTATIVE SHARED THE INFORMATION FROM TS WITH THE PHYSICIAN. IT WAS NOTED THAT THE PATIENT'S HEALTH HAD DETERIORATED SIGNIFICANTLY AND IT WAS UNKNOWN WHAT THE PHYSICIAN'S PLANS WERE FOR THIS PATIENT. AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. 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 DURING A ROUTINE IN-CLINIC FOLLOW UP, ELECTROGRAM (EGM) NOISE WAS OBSERVED ON THIS PACEMAKER, RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. SEVERAL ASVS MARKERS WERE OBSERVED AT RATES OF 200 BEATS PER MINUTE (BPM) AND HIGHER, HOWEVER, THE PATIENT'S ACTUAL RATE WAS NOTED TO BE IN THE 70 BPM RANGE. ADDITIONALLY, THE DEVICE WAS OBSERVED TO BE AT ELECTIVE REPLACEMENT NEAR (ERN) WITH A MAGNET RATE OF 91. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING OPTIONS TO MINIMIZE OVERSENSING AND DISCUSSED THE POSSIBILITY OF A LEAD ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155197 DELTA IMPLANTABLE PULSE GENERATOR NVZ HISTORICAL CPI ST. PAUL 0926

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 4266| 0926| 4260