BEUDAMED
    FDA Adverse Event Other Summary report: N

    KINETRA

    MDR report key: 2170216 · Received July 5, 2011

    Report

    Report Number
    3004209178-2011-05071
    Event Type
    Other
    Date Received
    July 5, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED REGARDING AN EXPIRED NEUROSTIMULATOR THAT WAS IMPLANTED AFTER THE EXPIRATION DATE.

    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 71 YR IMPLANTED:| EXPLANTED:| LOT# NHU186649V| LEAD: MODEL 3389S-40, LOT# V159795| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7428| LEAD: MODEL 3389S-40, LOT# V159795| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU186378V| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7436, LOT# NFU025205P| EXPLANTED: