BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4409348 · Received January 12, 2015

    Report

    Report Number
    3004209178-2015-00543
    Event Type
    Malfunction
    Date Received
    January 12, 2015
    Report Date
    December 19, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 377845, LOT# V010268, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 377845, LOT# V010268, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCES WITH THE 0 ELECTRODE AS A REFERENCE; ELECTRODES 4, 5, 6, 7, 12, 13, 14, AND 15 WERE ALL GREATER THAN 3,600 OHMS. ALL OTHER REFERENCES AND ALL OTHER COMBINATIONS WERE GOOD; THE ONLY OUT OF RANGE ELECTRODE WAS 0. THE PATIENT WAS NOT PROGRAMMED TO THE 0 ELECTRODE. THE PATIENT WAS PROGRAMMED ON 5, 6, AND 7 AND THERAPY WAS REPORTED TO BE GOOD. THE REASON FOR THE PATIENT¿S APPOINTMENT WAS A NOTIFICATION THE BATTERY WOULD NEED REPLACING SOON. NO INTERVENTIONS OR OUTCOME WERE 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
    25841 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1