BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4140879 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18295
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 9, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 708140, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT GOT HER DEVICE CHECKED ON THE DAY PRIOR TO THE REPORT AT THE HEALTH CARE PROFESSIONAL¿S OFFICE AS SHE WAS HAVING TO RECHARGE MORE THAN NORMAL. IT WAS NOTED, THE PATIENT WOULD EXPERIENCE PERIODS OF OVERSTIMULATION AND SHOCKING AND WAS TOLD THAT SHE MAY NEED AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT. THE PATIENT STATED THAT THE STIMULATION WAS SET TO A LOWER LEVEL BECAUSE OF THIS. IT WAS NOTED THAT SYMPTOMS HAD A GRADUAL ONSET AND THE CHANGE WAS NOTICED ABOUT 3-4 WEEKS PRIOR TO THE REPORT. THE PATIENT STATED THAT IN THAT TIMEFRAME, SHE WAS SHOCKED TWICE AT THE GROCERY STORE. IT WAS NOTED THAT THE PATIENT WAS IN BETWEEN PAIN MEDICATIONS AS THE HEALTH CARE PROFESSIONAL DID NOT PROVIDE HER WITH ANY ON THE DAY PRIOR TO THE REPORT. THE REPORTER NOTED THAT THE PATIENT WOULD HAVE A REPLACEMENT PROCEDURE. IT WAS NOTED THAT THE PATIENT PROGRAMMER WAS EITHER LOST OR STOLEN AFTER THE PATIENT LEFT THE HEALTH CARE PROFESSIONAL¿S OFFICE ON THE DAY PRIOR TO THE REPORT. IT WAS LATER NOTED THAT THE PATIENT WAS PROVIDED WITH ANOTHER PATIENT PROGRAMMER. 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
    619721 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 00061 YR Required Intervention