BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4210294 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20592
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    October 24, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37751, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8577, LOT# N190625, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THE REPLACEMENT AS PLANNED AND WAS DOING FINE AFTER THAT. THERE WERE NO FURTHER ISSUES. IT WAS NOTED THAT THE PATIENT HAD THE ISSUES 4 TO 5 MONTHS PRIOR TO THE ORIGINAL REPORT. IT WAS ALSO NOTED THAT NO DEVICES WERE TO BE RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROBLEM WITH THE PATIENT PROGRAMMER (PP) AND IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) FOR ABOUT A MONTH. THE PP WAS NOT POWERING UP AND IT HAD NOT BEEN DROPPED OR GOTTEN WET, AND IT HAD NO CORROSION. HE WAS USING ENERGIZER BATTERIES AND THEY WERE POSITIONED CORRECTLY. THE INSR WAS NOT RECHARGING THE IMPLANT INSIDE OF HIM AND WOULD NOT INTERROGATE AND HE HAD THIS ISSUE FOR ABOUT A MONTH. HE DID NOT KNOW WHAT WAS COMING UP ON THE SCREEN. A MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT AT THE HEALTHCARE PROVIDER (HCP) OFFICE. THEY DID A REPROGRAMMING AND COUPLING SCAN FOR RECHARGING. IT WAS DETERMINED THAT THE PATIENT SHOULD SEE AN IMPLANTING PHYSICIAN FOR CONSULT ABOUT IMPLANTABLE NEUROSTIMULATOR (INS) REPOSITIONING. ABOUT A MONTH LATER IT WAS DETERMINED THAT THE PATIENT WOULD HAVE AN INS REPOSITIONING 3 DAYS LATER. THE PATIENT ALSO WANTED THE INSR AND PP REPLACED. THE PATIENT WAS UNDECIDED ABOUT WHETHER HE WANTED A NON-RECHARGEABLE OR RECHARGEABLE DEVICE. IT WAS NOTED THAT THE PATIENT HAD LOST A CONSIDERABLE AMOUNT OF WEIGHT AND WAS GOING TO CONTINUE TO TRY AND LOSE WEIGHT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694107 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 Required Intervention