BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 14082839 · Received April 12, 2022

    Report

    Report Number
    3004209178-2022-04573
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    March 16, 2022
    Report Date
    April 12, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00613994222084
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 121-267 LEAD, IMPLANTED: (B)(6) 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT FAMILY MEMBER THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) WAS UNABLE TO ESTABLISH TELEMETRY. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210494 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. ADDRL1 00613994222084

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female 407652 LEAD, 5867-3M ADAPTOR