BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3103194 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07415
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 18, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 355029, LOT# N0028594, IMPLANTED: (B)(6) 2006, PRODUCT TYPE ACCESSORY; PRODUCT ID 377760, LOT# V004018, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 377760, LOT# V004018, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A PATIENT HAD STIMULATION ON, HE GOT A SHOCKING SENSATION IN THE RIGHT HIP AND HAD TO TURN STIMULATION OFF. THE REPORTER STATED THAT WITH STIMULATION OFF THE IMPLANT SITE WAS VERY PAINFUL AND ¿MORE OF AN ACHE.¿ IT WAS REPORTED THAT THE PATIENT TURNED STIMULATION OFF ABOUT THREE WEEKS PRIOR TO THE REPORT DUE TO PAIN AT THE IMPLANT SITE. IT WAS NOTED THAT THE PATIENT HAD A COUPLING PROBLEM WITH THE DEVICE AND RECHARGER AND A DEVICE OVERDISCHARGE WAS SUSPECTED. AN ANTENNA LOCATE WAS DONE AND THE DEVICE SHOWED A POWER-ON RESET (POR) CONDITION AND THE PATIENT WAS ABLE TO CHARGE THE DEVICE. IT WAS NOTED THAT PATIENT COMPLIANCE WAS THE PRIMARY REASON FOR AN OVERDISCHARGE, AND THE LAST TIME THE PATIENT HAD A SUCCESSFUL RECHARGING SESSION AND FELT STIMULATION WAS ONE TO TWO MONTHS PRIOR TO THE REPORT. IT WAS REPORTED THAT THE PATIENT WAS ABLE TO FEEL THE DEVICE LEADS AND ALSO FELT A ¿KNOT THERE.¿ IT WAS FURTHER REPORTED THAT THE PATIENT FELT A KNOT WHEN HE TOUCHED WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED. IT WAS UNCLEAR WHERE THE PATIENT FELT THE KNOT. THE REPORTER STATED THAT WHEN THE DEVICE WAS IMPLANTED, THE PATIENT WAS TOLD THAT IT WOULD BE A ¿NEWER SMALLER¿ DEVICE AND IT WOULD BE IMPLANTED ¿ABOVE THE BELT LINE.¿ IT WAS INDICATED THAT THE PATIENT¿S PREVIOUS DEVICE WAS ¿BELOW THE BELT LINE.¿ IT WAS REPORTED THAT WHEN THE PATIENT WOKE FROM SURGERY THE DEVICE WAS IN ¿ALMOST THE EXACT SPOT¿ AS THE PRIOR DEVICE AND THE PATIENT HAD PAIN AT THE DEVICE SITE SINCE SURGERY. IT WAS NOTED THAT THE PAIN WAS DESCRIBED LIKE A ¿DULL ACHING THROB.¿ IT WAS REPORTED THAT THE PATIENT PLANNED TO FOLLOW UP WITH HIS DOCTOR REGARDING PAIN. THE NEXT DAY, IT WAS REPORTED THAT THE POR HAD BEEN CLEARED. THE REPORTER STATED THAT WHEN THE PATIENT¿S STIMULATION WAS ON IT WAS COMFORTABLE, BUT IF THE PATIENT MOVED HIS NECK A CERTAIN WAY, IT BECAME UNCOMFORTABLE AND RATHER PAINFUL. IT WAS NOTED THAT THE PATIENT WANTED TO KNOW IF THE PATIENT PROGRAMMER, THE BATTERY, OR THE LEAD WAS CAUSING THE PAIN. IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT WAS TRYING TO REACH HIS DOCTOR AND WANTED TO HAVE POSSIBLE REPROGRAMMING. 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
    203448 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