BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 8843575 · Received July 30, 2019

    Report

    Report Number
    3004209178-2019-14626
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    May 6, 2019
    Report Date
    July 30, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00643169708624
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-0806-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY HAD AN OBSERVATION RELATING TO PACING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED VENTRICULAR SENSE COUNTS IN THE LESS THAN 40 BPM BIN ON THE RATE HISTOGRAM. FOLLOW-UP WAS ATTEMPTED; HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED. THIS INCIDENT WAS NOT REPORTED BY A HEALTHCARE PROVIDER; THEREFORE, NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634101 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. ADDR01 00643169708624

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR