BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA SR

    MDR report key: 3992587 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14793
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT AN ELECTRICAL CURRENT THROUGH THEIR BODY. ATTEMPTS TO GAIN FURTHER INFORMATION WERE UNSUCCESSFUL AND RECORDS INDICATE THAT THE DEVICE 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
    470562 ADAPTA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADSR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00103 YR 407452 LEAD