BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3091782 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07236
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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 3487A-45, LOT# V341203, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT# V527691, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN OVERDISCHARGE SUSPECTED. IT WAS STATED THE PATIENT WAS IN AN OVERDISCHARGED STATE FOR OVER A YEAR. IT WAS ALSO STATED THE DAY PRIOR TO REPORT THE CALLER MET WITH THE PATIENT AND THREE PHYSICIAN MODE RECHARGES PMRS WERE PERFORMED AND GOT A NORMAL CHARGING SCREEN, BUT NO COUPLING BARS. IT WAS NOTED THE RECHARGER WAS MOVED '50+ TIMES.' NO SYMPTOMS WERE REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195082 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