BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3231743 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11897
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 24, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THE PATIENT HAD PAIN AND ¿CATCHING¿ WHEN STIMULATION WAS TURNED OFF. IT WAS FURTHER NOTED THERE WERE NO KNOWN ACCIDENTS OR INCIDENTS RELATED TO THIS EVENT. IT WAS REPORTED THAT THE PATIENT HAD ACUTE PAIN AT THE LEAD LOCATION. IT WAS NOTED THE PAIN WAS AT THE PATIENT¿S MIDDLE BACK AND AROUND TOWARD THEIR LEFT FRONT SIDE. THE REPORTER STATED THEY WOKE UP ON (B)(6) 2013 WITH ¿EXCRUCIATING¿ PAIN IN THEIR MID-BACK WHICH WAS MIGRATING TOWARDS THEIR LEFT FRONT SIDE WHERE THEY HAD NEVER HAD PAIN. IT WAS NOTED THE PATIENT WONDERED IF THE LEAD MOVED, BUT THE PATIENT DID NOT KNOW OF AN EVENT THAT WOULD HAVE CAUSED THE LEAD TO MOVE. IT WAS FURTHER NOTED THE PATIENT PLANNED TO HAVE AN X-RAY TO DETERMINE IF THE LEAD MOVED. IT WAS NOTED THE PATIENT DESCRIBED THE PAIN AS THE DEVICE ¿FIRING REAL HARD, SHOCKING, INTENSE, SHARP, AND TAKES YOUR BREATH AWAY.¿ IT WAS NOTED THE PAIN DID NOT GO DOWN THE PATIENT¿S LEGS. THE REPORTER STATED THAT STIMULATION WORKED WELL FOR THEIR ARM AND NECK PAIN AND HAD A ¿LEAD GOING DOWN MY RIGHT LEG FOR SCIATICA.¿ IT WAS NOTED THE INS WAS OFF AND DOWN TO 0.00 AND THE SHOCKING STOPPED, BUT THE PATIENT¿S PAIN REMAINED. IT WAS FURTHER NOTED THAT IF THE PATIENT TURNED A CERTAIN WAY THE PAIN ¿CATCHES¿ IN THEIR BACK AND THE PAIN WAS DEEP AND INTERNAL. THE REPORTER STATED THE PAIN STARTED ABOUT 5-6 INCHES ABOVE THE INS IN THE LEFT UPPER BUTTOCKS AND THEY HAD DIFFICULTY LYING DOWN OR SITTING IN A CHAIR. IT WAS NOTED THE PATIENT COULD NOT DRIVE BECAUSE THE SCIATICA MAKES THEIR LEGS GO TO SLEEP. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331070 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 00054 YR