BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2982603 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03144
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 7, 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

    PRODUCT ID: 3776-60 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID: 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD STIMULATION IN THEIR STOMACH FOLLOWING A FALL THREE WEEKS AGO. IT WAS STATED, THE PATIENT HAD PAIN AROUND THE GENERATOR SITE. IT WAS ALSO STATED, THE SYMPTOMS WERE REPORTED AROUND THE LEFT SIDE OF IMPLANT AND THE LEAD LOCATION. THE PATIENT TURNED STIMULATION OFF UNTIL THEIR APPOINTMENT. REPORTEDLY, THE REPRESENTATIVE WAS UNABLE TO REPROGRAM THE PATIENTS STIMULATION DUE TO THE BATTERY DISCHARGED. THE PATIENT WAS ENCOURAGED TO GO HOME AND CHARGE HIS BATTERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD TO GO HOME AND CHARGE THEIR DEVICE AND A WEEK LATER THEY WERE REPROGRAMMED. IT WAS STATED THAT AFTER THE PATIENT WAS REPROGRAMMED THEY LEFT WITH "GOOD COVERAGE". NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87771 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 00044 YR