BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1854176 · Received September 30, 2010

    Report

    Report Number
    3004209178-2010-07453
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 2, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SEE ALSO MANUFACTURER REPORT # 3004209178201007457. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. BEGINNING ON (B)(6) 2010, THE PATIENT DID NOT WANT TO OPEN THE EYES, AND WAS NOT WALKING AS WELL. THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2010, BECAUSE THE PATIENT'S "OXYGEN WAS LOW." IT WAS UNCLEAR WHETHER THE "LOW OXYGEN" WAS RELATED OR WHETHER THE PATIENT WAS ADMITTED TO THE HOSPITAL, AT THAT TIME. THE PATIENT'S SYMPTOMS BEGAN FOLLOWING SOME TYPE OF ENVIRONMENTAL EXPOSURE. ON (B)(6) 2010 AND (B)(6) 2010, THE PATIENT RECEIVED "VITAL STIM THERAPY" ON BOTH THE RIGHT AND LEFT SIDE OF THE PATIENT'S ADAM'S APPLE, "UP TO LIP OF CHIN." IT WAS NOTED THAT THE THERAPY WAS APPLIED AT A HIGHER SETTING, FOR ONE HOUR, AT THE LAST SESSION. THE PATIENT ALSO HAD "VITAL STIM THERAPY" FOR THE SIX WEEKS PRIOR TO THE END OF (B)(6) 2010, WITH NO CHANGES IN THE PATIENT'S THERAPY NOTED AT THAT TIME. NO FURTHER DETAILS, PATIENT'S SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FIELD IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 62 YR EXPLANTED:| LEAD, MODEL 3387, LOT# J0319999V| EXTENSION: MODEL 7495-51, LOT# XR0005459V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU014216V| LEAD: MODEL 3387, LOT# J0333759V| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| LOT# NFW148850H| EXPLANTED:| IMPLANTED: