BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3143350 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08571
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 16, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; 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 THE SYSTEM WAS AGGRAVATING THE PATIENT ¿REALLY REALLY BAD¿ FOR A COUPLE OF MONTHS. THE ISSUE HAD STARTED IN (B)(6) 2013. THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTH CARE PROVIDER (HCP) ON (B)(6) 2013 WHERE THE DEVICE WAS TURNED OFF. IT WAS STATED THE PATIENT TRIPPED ON AN AREA RUG AT THE END OF (B)(6) 2013. THE PATIENT STARTED TURNING IT DOWN AND ¿OFF BASICALLY¿ AS THE PATIENT TRIPPED AGAIN 2 WEEKS LATER, WHERE THE PATIENT WAS ¿HOPPING AND ALMOST FELL.¿ THE PATIENT STAYED IN THEIR CHAIR AND RESTED AS THEIR LEG WAS ¿REALLY SORE.¿ IT WAS STATED THE PATIENT HAD MET WITH A MANUFACTURER¿S REPRESENTATIVE ON (B)(6) 2013 AS ¿SOMETHING WAS GOING ON.¿ WHEN THE PATIENT WAS STANDING UP IT FELT GOOD, BUT WHEN THE PATIENT WENT HOME AND IN THEIR CHAIR AND SWIMMING POOL, ¿WHICH CAUSED IT TO VIBRATE.¿ IT WAS FURTHER NOTED THAT IT WAS AN ¿AGGRAVATION VIBRATION¿ AND THE PATIENT¿S HCP DID NOT KNOW THE CAUSE. THE PATIENT WAS TO RETURN TO THEIR HCP ON (B)(6) 2013 AND ¿FIGURE OUT THE NEXT STEPS.¿ IT WAS NOTED THE PATIENT DEALT WITH ¿A LOT OF PAIN ALL THE TIME.¿ IT WAS LATER REPORTED THE PATIENT HAD BEEN INSTRUCTED TO KEEP THE SYSTEM OFF FOR 1 MONTH. IT WAS STATED TESTING OF THE SYSTEM HAD SHOWN ALL SYSTEMS WERE FUNCTIONING WITHIN SPECS. ADDITIONAL INFORMATION FROM THE PATIENT¿S PHYSICIAN STATED THE PATIENT¿S ¿INCREASED VIBRATION¿ WAS DUE TO A ¿BREAK¿ OF THE LEAD. THE PATIENT¿S OUTCOME WAS LISTED AS ¿NO INJURY.¿ A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244237 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