BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1083479 · Received July 29, 2008

    Report

    Report Number
    3004209178-2008-04484
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, FOLLOWING IMPLANT, THE PATIENT EXPERIENCED A LACK OF EFFECT, ACUTE PAIN IN THE FACE, AND NAUSEA. THE PATIENT HAD THE IPG DEVICES ON FOR ONE DAY WITH GOOD RESULTS. FOLLOWING THE FIRST PROGRAMMING THE PATIENT THEN BEGAN EXPERIENCING THE PAIN IN THE FACE AND NECK (ALSO DESCRIBED AS A PAINFUL TINGLING SENSATION ON THE FACE (CHEEK, NOSE AND EYE AREAS). THE PATIENT ALSO EXPERIENCED A SENSITIVITY TO LIGHT AND NOISE, A PULLING SENSATION ON HER NECK, AND PAIN FROM THE WIRE IN HER NECK AND THE IPG IN HER CHEST. REPORTEDLY, THE WORST SYMPTOM WAS THE SEVERE NAUSEA. WHEN THE DEVICE WAS TURNED ON THE NAUSEA BUILT UP OVER TIME. THE PATIENT EXPERIENCED DRY-HEAVING AND BECAME DEHYDRATED DUE TO NOT EATING OR DRINKING. THE PATIENT WAS HOSPITALIZED FOR A FEW DAYS (DATE UNKNOWN) TO BE EVALUATED FOR INFECTION. THE PATIENT DID NOT HAVE AN INFECTION. THE PATIENT WAS PRESCRIBED STEROIDS WHICH DID HELP SOME. THE PATIENT HAD HER DEVICE TURNED OFF DUE TO THE RETURN OF SYMPTOMS WHEN TURNED ON. SEE MFR REPORT #3004209178200804483. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXPLANTED:| EXPLANTED:| LEAD MODEL 3389 LOT# V050299| IMPLANTED:| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU175110V