BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2983504 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03175
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    September 9, 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
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37743, 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 INCREASED PAIN IN HER BUTTOCK AND HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT KEEPING A CHARGE. IT WAS STATED THE PATIENT WAS CHARGING HER INS THREE TIMES A MONTH. IT WAS ALSO REPORTED THAT THE PATIENT HAD A "BULGE" IN HER BACK WHERE THE LEADS COME OUT OF HER INS. THE PATIENT SCHEDULED AN APPOINTMENT WITH HER HEALTHCARE PROVIDER FOR (B)(6) 2013. ON (B)(6) 2013 A POWER ON RESET CONDITION WAS REPORTED. CALLER PERFORMED PHYSICIAN MODE RECHARGE SUCCESSFULLY AND WAS AT A "NORMAL" CHARGING SCREEN. NO FURTHER INFORMATION WAS KNOWN AT THE TIME OF REPORT AND IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED, THE PATIENT WAS OVER DISCHARGED AND A PHYSICIAN MODE RECHARGE WAS PERFORMED. THE POWER ON RESET WAS CLEARED AND THE PATIENT WAS RECEIVING STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88094 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