BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3983182 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14006
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 14, 2014
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE RECHARGER; PRODUCT ID 3487A-45, LOT # J0331884V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT # J0331885V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FOR ABOUT THE PAST 6 MONTHS, THE STIMULATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WOULD REVERT BACK TO A ¿DEFAULT¿ PROGRAM A1 WHEN THEY TURNED IT ON IN THE MORNING EVENT THOUGH IT WAS SET ON A2 WHEN THEY TURNED IT OFF AT NIGHT. IT WAS ADVISED THAT THE STIMULATION SHOULD TURN BACK ON AT THE SAME PROGRAM AND SETTING AS WHEN IT WAS TURNED OFF AT BUT THE PATIENT STATED THAT THIS WAS NOT HAPPENING. THE PATIENT STATED THAT THE INS THERAPY ¿GIVES ME TERRIFIC RELIEF¿ BUT WOULD LIKE TO CHANGE THE ¿DEFAULT¿ PROGRAM. IT WAS NOTED THAT PROGRAM 1 WAS FOR THE PATIENT¿S BACK AND LOWER LEG AREAS, PROGRAM 2 WAS THE ¿FRONT¿ AND LOWER LEG, AND PROGRAM 3 WAS FOR THEIR BACK AND INTO THE THIGH AND LEG AREAS. IT WAS ALSO REPORTED THAT THE PATIENT HAD PERIPHERAL NEUROPATHY WHICH HAD COME ON IN THE LAST YEAR. WHEN CONTACTED FOR FOLLOW UP INFORMATION, THE PATIENT STATED THAT THEY RECEIVED ASSISTANCE FROM THEIR DOCTOR AND MANUFACTURER¿S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED WITH AN APPOINTMENT DATE OF ¿WITHIN (B)(6) 2014¿ NOTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461461 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR