BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 11553513 · Received March 23, 2021

    Report

    Report Number
    2182208-2021-01148
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    May 13, 2020
    Report Date
    March 23, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: RAPID VENTRICULAR PACING USING PRE-EXISTING IN-SITU PERMANENT PACEMAKER FOR TAVR IN LIEU OF TEMPORARY VENOUS PACEMAKER. STRUCTURAL HEART. 4:3, 240-242. DOI:10.1080/24748706.2020.1751365. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING RAPID VENTRICULAR PACING USING PRE-EXISTING IN-SITU PERMANENT PACEMAKER FOR TRANSCATHETER AORTIC-VALVE REPLACEMENT (TAVR). THE ARTICLE REPORTS ONE PATIENT WHOSE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO CAPTURE AT A ONE TO ONE RATE WHEN PACING AT 160 BEATS PER MINUTE. A TEMPORARY TRANS-VENOUS PACEMAKER (TVP) WAS USED. THE STATUS/ DISPOSITION OF THE DEVICE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452468 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR