BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLETRA

    MDR report key: 1083468 · Received July 29, 2008

    Report

    Report Number
    9614453-2008-04458
    Event Type
    Death
    Date Received
    July 29, 2008
    Date of Event
    March 28, 2008
    Report Date
    June 17, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR DEPRESSIVE SYMPTOMS IN 2008. A TREATMENT WITH CITALOPRAM WAS STARTED. THE PATIENT COMMITTED SUICIDE (BY HANGING) IN 2008. THE PATIENT WAS HYPERACTIVE AND MADE PROFESSIONAL PLANS FOR THE FUTURE THE DAY BEFORE COMMITTING SUICIDE. REFER TO MANUFACTURER REPORT # 9614453200804457

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC SWISS MANUFACTURING FACILITY 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death EXPLANTED| IMPLANTABLE NEURO STIMULATOR MODEL 7426| EXPLANTED| CITALOPRAM| DRUGS: ROPINIROLE| EXPLANTED| LEAD MODEL 3389 LOT# B0774035K IMPLANTED| LEAD MODEL 3389 LOT# B0774036K IMPLANTED| ODPERISONE| EXTENSION MODEL 7489 LOT# NHU165634V IMPLANTED| EXTENSION MODEL 7482 LOT# NHU165733V IMPLANTED| EXPLANTED| LOT# NFW636072S IMPLANTED| EXPLANTED