BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1071343 · Received July 1, 2008

    Report

    Report Number
    6000032-2008-03666
    Event Type
    Injury
    Date Received
    July 1, 2008
    Date of Event
    January 1, 2007
    Report Date
    June 3, 2008
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., MED REL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT FELT A SHOCKING OR JOLTING SENSATION AT THE LEAD LOCATION WHEN THE IMPLANTABLE NEUROSTIMULATOR WAS TURNED ON. THE PATIENT HAD HEADACHES AND TIGHTNESS NEAR HIS SCALP ON THE LEFT SIDE OF HIS HEAD. THE PATIENT EXPERIENCED ITCHING AT THE SCALP WHICH BECAME SEVERE AT NIGHT. THE PATIENT TURNED THE DEVICE OFF AT NIGHT. THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE SYMPTOMS STARTED AFTER A SEVERE FALL ONE YEAR AGO. HE FELL AGAIN THIS YEAR. THE PATIENT HAD MOVED SEVERAL TIMES AND WAS UNABLE TO FIND AN INTERIM HCP TO RESOLVE THE ISSUE. THE PATIENT WAS AT HOME AND HER STATUS WAS FAIR. IT WAS LATER REPORTED THAT THE PATIENT VISITED AN HCP; THE HCP PLANNED TO TAKE AN X-RAY OF THE NECK, HAVE A MANUFACTURER'S REPRESENTATIVE CHECK THE PATIENT'S DEVICE, AND POSSIBLY USE HEAT THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| EXPLANTED| LOT # NFW116789H| IMPLANTABLE NEURO STIMULATOR MODEL 7426| EXPLANTED| EXTENSION MODEL 7482| EXPLANTED| LEAD MODEL 3387-40| EXPLANTED| LEAD MODEL 3387| EXTENSION MODEL 7495LZ