BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3103637 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07479
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37092, LOT # 299270002, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 3708220, SERIAL #(B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL #(B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3888-33, LOT # V828947, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 355028, LOT # N313746, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 355028, LOT # N297276, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 355531, LOT # N302255, IMPLANTED: (B)(6) 2012, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 3487A-56, LOT # V549593, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V706697, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT # V716841, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THE PATIENT EXPERIENCED NAUSEA AND SEVERE DIZZINESS SINCE IMPLANT. IT WAS NOTED THE DOCTOR DOES NOT BELIEVE THESE SYMPTOMS ARE RELATED TO THE DEVICE BUT THEY ARE DOING AN MRI OF THE HEAD TO TRY AND FIND MORE ANSWERS. IT WAS REPORTED A COUPLE WEEKS LATER THE HEALTHCARE PROVIDER STATED THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THE DOCTOR WANTED TO GET AN MRI OF THE BRAIN TO RULE OUT CENTRAL NERVOUS SYSTEM PROBLEMS, BUT THE PATIENT REFUSED. IT WAS STATED THAT PATIENT WAS INSTRUCTED TO SEE A NEUROLOGIST. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD BEEN REPROGRAMMED AND AN EXPLANT WAS PLANNED FOR (B)(6) 2013 DUE TO THE NAU SEA THAT WAS CAUSED WHEN STIMULATION WAS TURNED ON. FURTHER INFORMATION RECEIVED REPORTED THAT ALL PRODUCTS WERE EXPLANTED FROM THE PATIENT. IT WAS ADDED THE PATIENT WAS DOING "FINE." IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203786 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention