BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3319379 · Received August 30, 2013

    Report

    Report Number
    3004209178-2013-15483
    Event Type
    Injury
    Date Received
    August 30, 2013
    Report Date
    August 5, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 74002, LOT # N240868, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ADAPTER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD LEG PAIN YESTERDAY. IT WAS NOTED THAT THE THREE PROGRAMS THE PATIENT USED ON PROGRAM A ALL WENT TO THE LEFT LEG AND THE PAIN AND STIMULATION WAS FAST AND SHARP. IT WAS NOTED THAT THE LAST PROGRAMMING SESSION WAS IN THE LAST MONTH OR TWO. IT WAS NOTED THAT THE PATIENT FELL A COUPLE WEEKS AGO. IT WAS NOTED THAT THE CURRENT SETTING FOR PROGRAM A WHICH WAS MEANT FOR UPRIGHT AND WORKING WAS, A1 AT 1.8 VOLTS FOR THE BACK, A2 AT 0.1 VOLTS FOR THE LEFT LEG AND A3 FOR 2.4 VOLTS FOR THE RIGHT LEG. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION AND STIMULATION IN THE WRONG LOCATION. IT WAS NOTED THAT THE PATIENT FELL 2 WEEKS AGO. IT WAS NOTED THAT FOR THE LAST FIVE DAYS EVERYTHING WAS GETTING WORSE. IT WAS NOTED THAT THE STIMULATION WAS NOT IN THE CORRECT LOCATION AND THE PATIENT FELT SHOCKING ALL THE WAY FROM THE BACK TO THE LEFT LEG. IT WAS NOTED THAT WHEN THE PATIENT RAN PROGRAM A1 AND A3 THEY SHOULD GET RIGHT SIDE COVERAGE BUT ONLY GOT STIMULATION ON THE LEFT SIDE. IT WAS NOTED THAT WHEN THE MANUFACTURER REPRESENTATIVE TRIED TO RUN AN IMPEDANCE TEST IT SHOCKED THE PATIENT AND THE REPRESENTATIVE HAD TO PRESS STOP. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN X-RAY WAS TAKEN BUT THE HEALTH CARE PROFESSIONAL (HCP) DID NOT HAVE THE ORIGINAL X-RAY TO COMPARE PLACEMENT WITH; HOWEVER, IT LOOKED LIKE THE LEAD WAS STILL IN THE CORRECT AREA. IT WAS NOTED THAT THE PATIENT WAS GOING TO SEE ANOTHER HCP WHO WAS GOING TO ASSESS THE PATIENT¿S STATUS FOR OTHER POSSIBLE SPINAL INTERVENTIONS OR SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS A MALFUNCTION OF THE LEAD AFTER THE PATIENT SLIPPED AND FELL IN (B)(6) 2013. THE REPORTER STATED THE ISSUE WAS TRAUMA. IT WAS NOTED THE PATIENT¿S LEAD WAS REPLACED ON 2013-(B)(6). IT WAS FURTHER NOTED THAT THE PATIENT WAS HOSPITALIZED AND THE PATIENT OUTCOME WAS THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428518 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 00060 YR Hospitalization| R