BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3163414 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10178
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 21, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT HAVE STIMULATION SENSATION. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿3/4 FULL,¿ BUT THE PATIENT HAD NO RELIEF OR SENSATION. THE INS WAS SET TO 6.90 AMPS AND WAS NORMALLY 3.20. THE PATIENT TRIED BOTH SIDES, BUT COULD NOT ¿FEEL ANYTHING.¿ THE INS WAS LAST USED THE (B)(6). THE PATIENT TURNED THE DEVICE ON THE MORNING OF THE (B)(6) AND HIS RIGHT LEG WAS ¿STILL DEAD.¿ THE PATIENT WAS ¿SUPPOSED TO SOMETIMES FEEL TINGLING/VIBRATION.¿ THE PATIENT TURNED THE INS UP TO 7.70 WHICH WOULD NORMALLY DRIVE HIM ¿OUT OF THE CHAIR,¿ BUT HE DID NOT FEEL ANY SENSATION. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. 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 THOUGHT HIS DEVICE HAD ¿QUIT¿ ON HIM. IT WAS NOTED THAT HE COULDN¿T ¿GET ANY FUNCTION OUT OF IT.¿ IT WAS NOTED THAT THE ¿INSTRUCTIONS AND THE GUY THAT CAME OUT DIDN¿T GIVE ME A LOT OF INSTRUCTIONS ON EXACTLY ON HOW TO CHARGE IT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264688 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 00069 YR