BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3853609 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10248
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT# V121706, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT THEIR HEALTHCARE PROFESSIONAL (HCP) MENTIONED THAT AT SOME POINT THEY WOULD NEED TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED, BUT THEY NEVER MENTIONED THE TIME FRAME FOR THIS. IT WAS NOTED THE PATIENT WENT FROM (B)(6) TO (B)(6) TO GET THE INS AND THEY HAVE NOW MOVED TO (B)(6). THE REPORTER STATED THAT THEIR THERAPY DID NOT WORK ANYMORE AND IT WAS NOT KEEPING UP WITH THEIR PAIN LEVEL. THE REPORTER FURTHER STATED THEY TRIED THE HIGHEST SETTINGS THAT THE INS COULD GO TO, BUT IT COULD NOT GENERATE ENOUGH TO GET PAIN UNDER CONTROL. IT WAS NOTED THE PATIENT DID NOT KNOW IF THEIR BODY ADJUSTED TO STIMULATION. IT WAS FURTHER NOTED THE PATIENT KNEW THAT THE THERAPY JUST STOPPED HELPING. THE REPORTER STATED THIS STARTED APPROXIMATELY THREE YEARS AGO. THE REPORTER FURTHER STATED THEY HAD NOT KEPT THE DEVICE CHARGED AND THEY WOULD LIKE THE DEVICE REMOVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332789 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 00038 YR Required Intervention