BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2935858 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01137
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE PHYSICIAN REPORTED THAT THE DEVICE WAS NOT A CONTRIBUTING FACTOR IN THE PATIENT'S FALL. IT WAS NOTED THAT THE PATIENT HAD TRIPPED AND FALLEN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CHANGE IN STIMULATION FOLLOWING A FALL ABOUT 2 MONTHS AGO. IT WAS STATED THAT STIMULATION WAS "NOT COVERING ALL THE WAY DOWN TO THE FOOT AS IT SHOULD." ANOTHER FALL WAS REPORTED THE DAY BEFORE REPORT. PATIENT REPORTED THAT ONE OF THE FALLS WAS SO HARD SHE BROKE HER RIBS. IF MORE INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41434 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1