BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1961601 · Received December 27, 2010

    Report

    Report Number
    3004209178-2010-10772
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    December 14, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PT WAS NOT ABLE TO ADJUST STIMULATION. THE STATUS LIGHTS WERE ASSESSED. THE RIGHT SIDE WAS OPERATING APPROPRIATELY. FOR THE LEFT SIDE ONLY THE TOP LIGHT AND BOTTOM STATUS LIGHT CAME ON. THE INTERNAL NEUROSTIMULATOR (INS) UNIT LIGHT WAS NOT RESPONDING. THE HEALTH CARE PROVIDER CONFIRMED THAT AROUND (B)(6) HIS INS WAS TURNED OFF BY A REFRIGERATOR MAGNET. HE WAS TAUGHT HOW TO USE HIS PT PROGRAMMER TO TURN IT BACK ON AND THERE WERE NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR IMPLANTED:| LEAD: MODEL 3389, LOT# J0437464V| LOT# NFW153276H| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU066988V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU066987V| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389, LOT# J0437464V| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,