BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2802862 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09475
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 26, 2012
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3487A, LOT# L75642, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD; (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT WAS GOING TO GET A REVISION. THE PATIENT STILL HAD NO STIMULATION, BUT IMPEDANCES HAD ALWAYS BEEN NORMAL. TWO DAYS LATER, IT WAS REPORTED THAT THE REVISION SURGERY TOOK PLACE ON (B)(6). THE LEAD AND EXTENSION WERE BOTH REPLACED. THE NEW LEAD WAS IMPLANTED IN THE CERVICAL SPINE AT THE LOCATION OF THE EXPLANTED LEAD. POST-OPERATIVE IMPEDANCE TESTING SHOWED NO ABNORMAL RESULTS. DURING THE PRE-OPERATIVE INTERVIEW, THE GROUP IMPEDANCES WERE WITHIN NORMAL RANGES, BUT WERE SLIGHTLY LOW. IT WAS REPORTED THAT THE REVISING SURGEON NOTICED A FRACTURE IN THE LEAD AT THE POINT WHERE THE LEAD ENTERED THE "FLAT CONNECTOR". IMPEDANCE MEASUREMENTS USING AN EXTERNAL NEUROSTIMULATOR SHOWED THE SAME IMPEDANCES AS TESTING WITH THE IMPLANTABLE NEUROSTIMULATOR. REPLACING THE POCKET ADAPTOR RESULTED IN THE SAME IMPEDANCES AS WELL. IT WAS STATED THAT PROBLEMS IN THE POCKET HAD BEEN ADEQUATELY RULED OUT. IT WAS NOTED THAT X-RAYS DID NOT REVEAL ANYTHING UNUSUAL. THE OUT-OF-REGULATION MESSAGE FROM (B)(6) COULD NOT BE REPLICATED. IT WAS STATED THAT THE STIMULATION WAS NOT PERCEIVED BY THE PATIENT; HOWEVER, SHE WOULD FEEL IT PERIODICALLY WITH MOVEMENT OF HER HEAD. IT WAS REPORTED THAT THE PATIENT WAS "RECOVERING FROM SURGERY WELL" AND HER STIMULATION HAD RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION AND A SHOCKING OR JOLTING SENSATION. UPON INTERROGATION OF THE DEVICE WITH THE CLINICIAN PROGRAMMER AN OUT OF REGULATION (OOR) MESSAGE APPEARED, AND THEN STOPPED FEELING STIMULATION. IT WAS STATED THAT IT STARTED "ABOUT A WEEK AGO INTERMITTENT THEN COMPLETELY STOPPED ABOUT 2 DAYS AGO". THE MANUFACTURER'S REPRESENTATIVE REPROGRAMMED THE DEVICE TO 10.5 VOLTS AND THE PATIENT DID NOT FEEL ANYTHING. NORMALLY THE DEVICE WAS PROGRAMMED AT 2.5-3 VOLTS. IMPEDANCES ON THE LEAD WERE ALL NORMAL, AND GROUP IMPEDANCES WERE ALSO NORMAL. THE PATIENT FELT INTERMITTENT SHOCKING IN THE UPPER ARM; THE LEAD WAS PLACED IN THE CERVICAL LOCATION. NO SHOCKING WAS REPORTED IN THE POCKET AREA. THE PHYSICIAN USED A "C-ARM" AND VISUALIZED NO SYSTEM BREAK AT THE POCKET OR WHERE THE LEAD EXTENSION EXISTS. THE PATIENT WAS REFERRED TO THE IMPLANTING PHYSICIAN. PATIENT OUTCOME WAS NOT PROVIDED. 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
    1 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