BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3429225 · Received October 25, 2013

    Report

    Report Number
    3004209178-2013-19650
    Event Type
    Malfunction
    Date Received
    October 25, 2013
    Date of Event
    September 30, 2013
    Report Date
    October 2, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3998, LOT# V121145, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD STIMULATION IN THE WRONG LOCATION. THE STIMULATION SHOULD BE TREATING HER LEFT SIDE, HOWEVER, THERE WAS NO RELIEF ON THE LEFT AND THE STIMULATION WAS ON THE RIGHT SIDE. THE PATIENT STATED THAT WHEN STIMULATION WAS TURNED OFF, SHE COULDN¿T BREATHE. THE PATIENT STATED SHE WAS UNABLE TO BREATHE WHEN THE STIMULATION WAS AT THE WRONG LOCATION. THE PATIENT ALSO STATED IT WAS HARD TO EXPLAIN THE SENSATION. THE PATIENT ALSO FELT ¿A LITTLE BIT¿ OF SHOCKING ON THE RIGHT SIDE OF THE BACK OF HER KNEE. THERE WAS NO ACCIDENT OR INCIDENT. THE PATIENT STATED THAT SHE KNEW WHEN TO CHARGE WHEN THE STIMULATION STARTED TO ¿WANE¿ DOWN AND ¿VIBRATE.¿ THE PATIENT HAD FULLY CHARGED 2 DAYS PRIOR TO THE REPORT, TURNED THE STIMULATOR BACK UP TO HER NORMAL LEVEL, AND THAT¿S WHEN SHE NOTICED THE STIMULATION WAS GOING TO THE RIGHT SIDE. THE PATIENT NOTICED THE MODE WITH THE ¿ZZZ¿ ICON WAS SET, LIKE WHEN SHE WAS SLEEPING. THE PATIENT WAS UNABLE TO CONFIRM THIS WITH HER PATIENT PROGRAMMER AT THE TIME OF THE REPORT. OF NOTE, THE PATIENT HAD TERRIBLE PAIN IN HER NECK THAT STARTED 2 DAYS PRIOR AND WONDERED IF IT WAS RELATED TO HER STIMULATION. THE PATIENT STATED SHE WAS ¿EATING PAIN PILLS MORE THAN SHOULD BE.¿ IT WAS CLARIFIED THAT THE STIMULATION WAS SUPPOSED TO GO DOWN HER LEFT ARM. IT WAS ALSO CLARIFIED THAT THE STIMULATION WAS FELT BEHIND HER RIGHT KNEE. IT WAS FURTHER REPORTED THAT A COMPANY REPRESENTATIVE WAS ABLE TO REPROGRAM THE PATIENTS DEVICE. THE PATIENT WAS GETTING EFFECTIVE THERAPY FOR BOTH ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549410 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR