BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2946235 · Received February 6, 2013

    Report

    Report Number
    3004209178-2013-01371
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999. PRODUCT TYPE: EXTENSION: PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3387-40, LOT# L67121, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) FOR PNEUMONIA. IT WAS STATED THE DEVICE AFFECTED THE PATIENT'S SPEECH "SOME" WHILE IT WAS ON. THEREFORE, IT WAS DESIRED THAT THE DEVICE WOULD BE TURNED OFF SO THE PATIENT COULD SPEAK AND SWALLOW MORE EASILY. TWO DAYS LATER, IT WAS REPORTED THE PATIENT WAS IN ICU AND WAS HOSPITALIZED. IT WAS STATED THE PATIENT WAS "UNRESPONSIVE" AND THAT CONDITION WAS "POSSIBLY" DEVICE RELATED. IT WAS STATED A CT SCAN WAS COMPLETED AND AN MRI WAS TO BE PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED, THE PATIENT HAD RECOVERED BUT WAS STILL HAVING ISSUES SWALLOWING. IT WAS REPORTED, THE PATIENT'S MEDICATION HAD BEEN CHANGED AND THE PATIENT WAS DOING "10 TIMES BETTER," BUT THE PATIENT WAS JITTERY, NERVOUS AND EXPERIENCED PAIN IN THEIR LEGS. IT WAS ALSO REPORTED, THE PATIENT WAS SCHEDULED TO SEE THEIR DOCTOR FOR A FOLLOW-UP ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50319 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O