BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3223805 · Received July 12, 2013

    Report

    Report Number
    3007566237-2013-02328
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS FILED AS MFG. REPORT # 3007566237-2013-02328. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE CORRECT MANUFACTURING SITE WAS SITE (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7427V, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37082, IMPLANTED: (B)(6) 2013: PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006: PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006: PRODUCT TYPE EXTENSION; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006: PRODUCT TYPE EXTENSION; PRODUCT ID 3093-28, LOT# V013943, IMPLANTED: (B)(6) 2006: PRODUCT TYPE LEAD; PRODUCT ID 3093-28, LOT# V013728, IMPLANTED: (B)(6) 2006: PRODUCT TYPE LEAD. DEVICE USED FOR OFF LABEL INDICATION.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT A CHECK OF IMPEDANCES 1 HOUR POST-OP WERE NORMAL. IT WAS ALSO NOTED THAT AT THAT SAME TIME THE PATIENT EXPERIENCED COMFORTABLE STIMULATION FROM THE DEVICE. NO FURTHER INFORMATION WAS AVAILABLE BUT IT ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE OPERATING ROOM, WHERE THE PATIENT RECEIVED A NEW EXTENSION AND INS, THERE WAS AN IMPEDANCE ISSUE WITH LOW OUT OF RANGE IMPEDANCE VALUE. THEY SAW <(><<)>50 OHMS ON 4/7 WHEN TESTED AT DEFAULT (.7V) . THEY READ >10000 OHMS ON THE OTHER REMAINING PAIRS. IT WAS RECOMMENDED RUNNING EXHAUSTIVE IMPEDANCE TEST AT 1.5V OR 3.0V IF THE PATIENT COULD TOLERATE. HCP (HEALTHCARE PROVIDER) WAS JUST CLOSING SO THE REPRESENTATIVE HAD TO WAIT TO RERUN IMPEDANCES. THE REPRESENTATIVE RERAN THEM BUT COULD NOT UNDERSTAND THE VALUES BEING READ BACK TO THEM. PER ANOTHER PERSON IN THE ROOM, THEY WEREN'T GOING TO WORRY ABOUT THEM AT THIS POINT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324469 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR