BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3190472 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10902
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    March 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID 97791, LOT# N375354, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION. IT WAS NOTED THAT THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER WHICH WAS RESOLVED BY "REVIEWING THE APPLICABLE BATTERY CONSIDERATIONS". LESS THAN THREE WEEKS LATER, IT WAS REPORTED THAT THE PATIENT WAS SHOCKED IN THE RECOVERY ROOM WHEN THE STIMULATION WAS TURNED ON AND "THIS WENT ON FOR A LONG TIME, SEVERAL MINUTES SEEMED LIKE A HALF HOUR TO PATIENT'S HUSBAND." IT WAS STATED THAT WHEN SHE WAS "GOING THROUGH THIS" SHE WAS GIVEN PAIN MEDICATIONS AND "WAS NOT THINKING CLEARLY." IT WAS UNCLEAR WHAT "THIS" REFERRED TO. IT WAS STATED THAT THE PATIENT KEPT BEING ASKED IF SHE COULD FEEL IT, "BUT THE SETTING GOT UP TOO HIGH." IT WAS STATED THAT "IT WAS FINE WHEN THE MANUFACTURER'S REPRESENTATIVE WAS THERE AND LEFT IT UP THAT HIGH" AND THAT "SHE HAD FIGURED THAT'S WHAT THE PATIENT SAID." IT WAS STATED THAT, WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SHOCKING, THE PATIENT FELT IT IN THE LEGS AND "COULDN'T STAND THE PAIN." IT WAS STATED THAT "NO NURSES OR DOCTORS KNEW ANYTHING ABOUT HOW TO TURN THE PATIENT PROGRAMMER ON OR OFF AND THEY KEPT CALLING AND CALLING AND FINALLY GOT THROUGH TO SOMEONE TO TURN IT OFF AND DOWN." IT WAS STATED THAT THE PATIENT PASSED OUT AFTER THIS AND SHE WAS THANKFUL THAT HER HUSBAND WAS THERE. IT WAS STATED THAT A COMPANY REPRESENTATIVE "SWAPPED OUT" THE PATIENT'S PROGRAMMER AND REPROGRAMMED THE BATTERY. THE PATIENT WAS REPORTED TO BE "FINE".

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT RECEIVED AN ERROR MESSAGE ON THEIR PATIENT PROGRAMMER. IT WAS NOTED THAT THE PATIENT WAS HAVING TROUBLE ADJUSTING THEIR STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290857 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1