BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3203493 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11211
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 355531, LOT# N308038, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: SCREENING DEVICE: PRODUCT ID 3550-39, LOT# N305892, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY: PRODUCT ID 37092, LOT# 298480001, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3550-P4, LOT# N301443, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3550-54, LOT# UNKNOWN. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE POCKET REVISED ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT HAD TROUBLE WITH THE DEVICE IN THE BACK BECAUSE SHE HAD A LOT OF PAIN FROM BACK SURGERY. THE PATIENT REPORTEDLY HAD SEVERAL MINOR SURGERIES. IT WAS FURTHER NOTED THAT THE PATIENT¿S HEALTH CARE PROVIDER DECIDED TO MOVE THE DEVICE TO THE FRONT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301479 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention