BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 3993496 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14611
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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 PRIOR TO USE, WHEN THE PHYSICIAN REMOVED THE DEVICE FROM THE PACKAGE, THE SILICONE GROMMET WAS STICKING OUT SIDEWAYS. WHEN HE ATTEMPTED TO PUSH IT IN, THE SETSCREW FELL OUT. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED. THERE WAS NO APPARENT PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467025 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR