BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1890195 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-08297
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    August 13, 2010
    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
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION THERAPY NEVER PROVIDED RELIEF FROM PARKINSON'S SYMPTOMS AND THE PT KEPT THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF. THE PT NOTICED THAT THE INS HAD BEEN TURNING ON AND CAUSING A "QUIVER IN THE LIPS AND EYES." THE PT PROGRAMMER WAS THEN USED TO TURN THE INS OFF AGAIN. THE PT HAD A MAGNETIC PAD UNDER THE BED TO HELP "BALANCE A PERSON'S MAGNETIC FIELD." ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE. SEE MFR REPORT #3004209178-2010-08296 REGARDING THE SECOND STIMULATOR.

    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 57 YR IMPLANTED:| IMPLANTABLE NEURO STIMULATOR| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NGK014666N| IMPLANTED:| LEAD: MODEL 3389, LOT# J0110789V| IMPLANTED:| LEAD: MODEL 3389, LOT# J0110789V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NGK014666N| EXPLANTED:| EXPLANTED:| EXPLANTED:| MODEL 7426, LOT# NFW142726H