BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3113683 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07699
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 29, 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
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7489 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3 7752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 399930 LOT# V182611, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708340 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3708340 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. ACUTE PAIN WAS REPORTED. THE PATIENT'S SYMPTOMS OCCURRED OVER THE PAST 6 MONTHS. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE SYMPTOMS. IT WAS FURTHER REPORTED, THE PATIENT EXPERIENCED A SHOCKING SENSATION WHEN STIMULATION WAS INCREASED. THE LOCATION OF THE PATIENT'S SYMPTOMS WERE REPORTED TO HAVE BEEN IN THEIR HAMSTRING AREA AND BACK OF THE LEG WHERE THE SCIATIC NERVE WAS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS HAVING ¿MORE CHRONIC PAIN AS OF LATE, AND THE STIMULATION DOESN¿T REACH AS FAR AS IT USE TO.¿ THE PATIENT STATED THAT HE WOULD GET A ¿REALLY BAD JOLT¿ IF HE TURNED STIMULATION UP EXTREMELY HIGH AND THEN MOVED. THE PATIENT NOTED THAT ¿IF YOU TURN IT UP TO HIGH, THE LEG WILL CRAMP UP BECAUSE THE STIMULATION IS TURNED UP SO HIGH THAT IT CRAMPS THE MUSCLE INSTEAD OF DRIVING THE PAIN DOWN.¿ THE PATIENT REPORTED THAT THE PAIN AS WELL AS THE SHOCKING WAS FELT IN THE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214441 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