BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2023096 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01396
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 7, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S NEUROSTIMULATOR WAS TURNING OFF AFTER USING TO HER CORDLESS PHONE ON THE SAME SIDE AS HER IMPLANT. SHE ALSO BELIEVED THAT IT COULD BE RELATED TO HER "REMOTE" AND WAS GOING TO OBTAIN A LOANER DEVICE FROM HER HEALTHCARE PROFESSIONAL. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU090814V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V006969| EXPLANTED:| PROGRAMMER: MODEL 7436, LOT# NFU009039P| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU090819V| EXPLANTED:| LEAD: MODEL 3387, LOT# J0519661V| IMPLANTED:| IMPLANTED: