BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3022038 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04268
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 8, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LET THE BATTERY GO DEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BATTERY WAS REPLACED. IT WAS FURTHER REPORTED THAT THE REASON FOR REPLACEMENT WAS BECAUSE THE PATIENT 'WAS NOT RECHARGING' AND THAT HE 'THOUGHT IT WAS A BOTHER.' IT WAS REPORTED THAT THE RECHARGEABLE DEVICE WAS REPLACED WITH A PRIMARY CELL DEVICE IN (B)(6) 2011. NO FURTHER INFORMATION WAS KNOWN AT THE TIME OF REPORT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124471 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 Required Intervention