BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4131576 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18044
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 26, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE ABOUT 1-2 YEARS AGO THE PATIENT¿S STIMULATION WAS CAUSING A PROBLEM UNDER THE PATIENT¿S RIGHT SHOULDER BLADE, SPECIFICALLY A KNOT THE SIZE OF A FIST. IT WAS STATED THAT A MANUFACTURER¿S REPRESENTATIVE WAS NOTIFIED 6-7 MONTHS AGO AND THEY DECREASED STIMULATION AT THAT TIME. IT WAS REPORTED THAT SINCE THEN THE PATIENT HAS GONE TO A CHIROPRACTOR 2-3 TIMES PER WEEK AND THE KNOT ¿GOT BETTER/WASN¿T SO BAD.¿ IT WAS STATED THAT AT ONE POINT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WENT DEAD AND THE PATIENT WAS WITHOUT STIMULATION FOR A FEW DAYS. THE PATIENT NOTICED AFTER HE CHARGED AND TURNED STIMULATION ON THE KNOT RETURNED AND CAUSED BACK SPASM. THE CALLER SAID IT WAS VERY APPARENT AND TOOK ONLY A FEW MINUTES TO START. IT WAS NOTED THAT THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) WANTED THE PATIENT TO SEE A MANUFACTURER¿S REPRESENTATIVE BUT THE INDIVIDUAL WHO HAD WORKED WITH THE PATIENT PREVIOUSLY NO LONGER WORKED THERE. THE CALLER MENTIONED HE HAS TURNED STIMULATION OFF DUE TO THE KNOT. IT WAS LATER REPORTED THAT THE PATIENT HAD AN ¿ISSUE¿ WITH THE STIMULATOR. IT WAS THOUGHT THAT ¿NOTHING AT ALL WAS WORKING¿ IN THE PATIENT¿S STIMULATOR AND THAT IT WAS OFF. IT WAS NOT KNOWN IF A MANUFACTURER REPRESENTATIVE HAD CHECKED THE DEVICE OR WAS INVOLVED. THE PATIENT CAME IN THE WEEK PRIOR TO (B)(6) 2014 FOR SOME ¿OTHER ISSUE¿ THAT WAS NOT RELATED TO THE MANUFACTURER¿S DEVICES. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612738 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR