BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3307967 · Received August 26, 2013

    Report

    Report Number
    3004209178-2013-15136
    Event Type
    Malfunction
    Date Received
    August 26, 2013
    Date of Event
    June 1, 2013
    Report Date
    July 31, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37713, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-33, LOT# V651966, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT# V829967, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V763709, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V763709, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V741665, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-56, LOT# V741122, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V714604, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3888-56, LOT# V741122, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS STIMULATION IN THE WRONG LOCATION. IT WAS REPORTED THE PATIENT HAD FALLEN A ¿COUPLE OF TIMES¿ IN THE PAST MONTHS AND REPORTED GREAT COVERAGE BEFORE THE FALL. IT WAS REPORTED THE PATIENT DID NOT FEEL STIMULATION IN THEIR LEGS AND NOW FELT IT IN THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET. IT WAS NOTED THAT REPROGRAMMING THE ¿TOP AND BOTTOM¿ ELECTRODES THE PATIENT WAS NOT ABLE TO ¿CAPTURE LEGS OR BACK PAIN.¿ IT WAS REPORTED THE PATIENT COULD CAPTURE THE RIGHT LEG, BUT HAD INS SHARP PAIN. IT WAS REPORTED THAT WITH STIMULATION OFF, THEY WERE ¿UNABLE TO REPRODUCE WITH PALPATION.¿ IT WAS REPORTED WITH STIMULATION ON THE PATIENT FELT ¿UNCOMFORTABLE¿ AND REPORTED ¿ONE SPOT BY THE HEADER BLOCK.¿ IT WAS REPORTED THE IMPEDANCE READINGS WERE ¿>10000 OHMS.¿ IT WAS REPORTED THE IMPEDANCE TESTED AT DEFAULT SETTINGS ALL IMPEDANCES SHOWED >10,000 OHMS. IT WAS NOTED ¿WHEN INCREASED¿ IMPEDANCES WERE SHOWN BETWEEN 12-14K OHMS EXCEPT 10/11 WHICH WAS 150 OHMS. IT WAS NOTED AT 3V, IT WAS 9-11K OHMS. IT WAS NOTED THE PATIENT WAS ON 4 PROGRAMS. PROGRAM A1 WAS 2.7V/390/45 4+5-6- >4K OHMS. PROGRAM A2 WAS 1.8V/360/45 0+1-2+ >4KOHMS. PROGRAM A3 WAS 1.75V/270/45 12+15- 1441 OHMS. PROGRAM A4 WAS 1.9V/270/45 8+11- 1414 OHMS. IT WAS NOTED THAT WITH PROGRAM 3 THE PATIENT FELT NO STIMULATION IN THEIR BACK AND HAD NO LEG COVERAGE. IT WAS REPORTED ON PROGRAM 4 THE PATIENT ¿FELT IT AROUND THE INS POCKET, TINGLING SENSATION NOT AS SHARP.¿ IT WAS NOTED THAT REPROGRAMMING ATTEMPTS DID NOT RESOLVE THE ISSUE. ADDITIONAL INFORMATION REPORTED THE PATIENT WAS REPROGRAMMED ¿AROUND THE HIGH IMPEDANCE LEADS.¿ IT WAS REPORTED THE ¿OFFICE¿ WAS TO PERFORM X-RAYS WHEN THE PATIENT RETURNS FOR FOLLOW-UP NEXT MONTH. SEE REPORT NUMBER 3004209178-2013-15128 FOR CONCOMITANT INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415796 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 00059 YR