BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3092472 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07275
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377675, LOT# V005601, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3550-29, LOT# N184505, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: ACCESSORY: PRODUCT ID 377675, LOT# V005601, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS CHARGING MORE THAN EXPECTED. IT WAS NOTED THE RECHARGE INTERVAL DID NOT APPEAR TO HAVE BEEN APPROPRIATE. IT WAS STATED THAT STARTING ABOUT A YEAR PRIOR THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULD NOT STAY CHARGED AS LONG. AT THE TIME OF REPORT STIM WAS OFF. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS SUPPOSED TO BEING GOING IN FOR AN MRI ON THE PATIENT¿S SHOULDER. IT WAS NOTED THAT THE PATIENT COULD NOT DO AN MRI BECAUSE OF THE DEVICE. COMPATIBILITY GUIDELINES WERE DISCUSSED. IT WAS NOTED THAT THE PATIENT WAS GOING TO SCHEDULE A CAT SCAN. IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING. IT WAS REPORTED THAT THE PATIENT COULD NOT KEEP THE BATTERY CHARGED. IT WAS NOTED THAT BATTERY WOULD ONLY LAST A DAY, DAY AND A HALF. IT WAS REPORTED THAT THE PATIENT HAD LOW SETTINGS. IT WAS NOTED THAT THE BATTERY WAS WORKING FOR A WHILE, AND THEN ALL OF A SUDDEN THE BATTERY STARTED GOING LESS AND THEN LESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194452 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