BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2933748 · Received January 29, 2013

    Report

    Report Number
    3004209178-2013-01092
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BURNING SENSATION AT THE DEVICE SITE THAT ONLY OCCURRED WHEN RECHARGING. IT WAS NOTED THAT THIS HAD BEEN GOING ON SINCE THE DEVICE WAS IMPLANTED. THE REPORTER STATED THAT OVER THE LAST SEVERAL WEEKS BEFORE THE REPORT, A HALF-DOLLAR-SIZED AREA OVER THE DEVICE HAD TURNED EXTREMELY SENSITIVE TO TOUCH AND PRESSURE AND IT HURT THE PATIENT. THERE WAS NO REDNESS AND NO SIGNS OF INFECTION. THE CLINICIAN WANTED TO REMOVE THE DEVICE AND TRY A DIFFERENT LOCATION. IT WAS REPORTED THAT ANOTHER RECHARGER HAD BEEN TRIED, BUT THE PROBLEM DID NOT RESOLVE. THE PATIENT ALSO USED A CLOTH IN BETWEEN THE TELEMETRY HEAD AND THE SKIN, BUT THE PROBLEM DID NOT RESOLVE. IMPEDANCES WERE UNKNOWN AT THE TIME. SIX DAYS LATER, IT WAS REPORTED A PHYSICIAN MODE RECHARGE WAS TRIED ON ANOTHER PART OF THE BODY TO ASSESS IRRITATION TO RECHARGING. THIS WAS DONE FOR 15 MINUTES AND THE PATIENT DID NOT FEEL A SENSATION SIMILAR TO HOW HE FELT WHEN RECHARGING HIS DEVICE. IT WAS NOTED THAT THE PATIENT'S PAIN WAS COMING FROM A VERY SMALL SPOT OVER THE DEVICE, "ABOUT THE SIZE OF A DIME." IT WAS REPORTED THAT THIS AREA FELT LIKE IT WAS VERY SUPERFICIAL AND THERE WAS NO ADIPOSE TISSUE BETWEEN THE SKIN AND THE DEVICE. THE PATIENT'S DOCTOR HAD NOT ASSESSED THE DEVICE SITE. IT WAS NOTED THAT THE PATIENT HAD LOST A LOT OF WEIGHT. NO OTHER TROUBLESHOOTING WAS DONE AT THE TIME. A MONTH LATER, IT WAS REPORTED THAT THE DEVICE WAS GOING TO BE MOVED TO THE PATIENT'S OTHER SIDE. IT WAS NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY UNCOMFORTABLE STIMULATION WHEN THEY TRIED A RECHARGE ON A DIFFERENT AREA OF HIS BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38801 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