BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3598032 · Received January 29, 2014

    Report

    Report Number
    3004209178-2014-01351
    Event Type
    Injury
    Date Received
    January 29, 2014
    Date of Event
    December 25, 2013
    Report Date
    January 9, 2014
    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 Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7438, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT # V080811, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DURING CHRISTMAS THE IMPLANTABLE NEUROSTIMULATOR (INS) ¿SOMEHOW WAS TURNED OFF¿ AND THE PATIENT WAS ¿PARALYZED.¿ IT WAS NOTED THAT ¿THEY SWITCHED SOMETHING¿ AND THE PATIENT WAS BETTER. IT WAS NOTED THAT IT WAS TURNED BACK ON ¿A FEW HOURS LATER.¿ THE CALLER STATED THAT THE PATIENT WAS IN THE OFFICE AT THE TIME OF THE CALL. IT WAS NOTED THAT THE PATIENT WAS WALKING WITHOUT A CANE AND WAS BACK TO NORMAL BUT ¿FELT A LITTLE SLOW.¿ IT WAS NOTED THAT THE PATIENT HAD THE INS FOR PARKINSON¿S. THE CALLER INQUIRED ABOUT HOW TO CHECK THE DEVICE AND WHO TO CALL, A SURGEON ¿IN CASE IT NEEDS TO BE PLACED.¿ IT WAS FURTHER REPORTED THAT THE CALLER WANTED TO KNOW HOW LONG THE BATTERIES LAST ON AVERAGE ON HOW OFTEN THEY SHOULD BE CHECKED. THE CALLER DID NOT HAVE THE SETTINGS, DID NOT HAVE A CLINICIAN PROGRAMMER AND THE PATIENT DID NOT HAVE THEIR PATIENT PROGRAMMER WITH THEM. THE CALLER ALSO NOTED THAT THE PATIENT HAD PROGRAMMER THAT HAD ¿YELLOW BLINKING LIGHT.¿ ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63444 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Other