BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3241402 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12122
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    September 13, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SYNCHED WITH THE INS AND SAW THAT IT WAS FULL, TURNED OFF, AND THE PROGRAMMER BATTERY WAS AT A QUARTER. THE PATIENT WAS ON GROUP A ON PROGRAM 1, BUT STIMULATION WAS SET AT 0.00V. WHEN STIMULATION WAS TURNED BACK ON AGAIN IT REACHED THE MAXIMUM AT 0.50V. THE PATIENT DIDN¿T FEEL STIMULATION. IT WAS REPORTED THAT THE PATIENT WAS ZAPPED WHEN SHE USED THE PROGRAMMER, AND NOW THE HCP DIDN'T WANT HER TO USE THE DEVICE ANYMORE. IT WAS NOTED THAT THE PATIENT WAS NOT GETTING PAIN RELIEF FROM STIMULATION. IT WAS LATER CLARIFIED THAT THE PATIENT FELT ZAPPED BECAUSE STIMULATION WAS TOO HIGH, THUS THE HCP PUT A LIMIT ON HOW HIGH STIMULATION SHOULD BE SET, WHICH WAS AT 0.50V. A MANUFACTURER REPRESENTATIVE PLANNED TO FOLLOW-UP WITH THE PATIENT AND PERHAPS ADJUST STIMULATION SINCE THE PATIENT WASN'T GETTING PAIN RELIEF. IT WAS LATER REPORTED THAT THERE WAS NO PLANNED INTERVENTION. THE PATIENT WAS PAIN FREE AND DOING GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341512 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