BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3420619 · Received October 21, 2013

    Report

    Report Number
    3004209178-2013-19397
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Date of Event
    September 19, 2013
    Report Date
    October 1, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 377745, LOT# V001497, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PROGRAMMER DISPLAYED A POWER ON RESET (POR). THE POR WAS NOTED WITHIN THE WEEK PRIOR TO THE REPORT. STIMULATION WAS NOT WORKING AND THE PATIENT LAST FELT STIMULATION ON (B)(6) 2013. THERE WAS NO KNOWN REASON FOR THE POR. THERE HAD NOT BEEN ANY MEDICAL PROCEDURES. THE PATIENT DID NOT USE STIMULATION EVERY DAY. THE POR WAS ATTEMPTED TO BE CLEARED, BUT THE CLINICIAN PROGRAMMER WOULD NOT COMMUNICATE. THE RECHARGER SHOWED THE STIMULATOR BATTERY ¾ FULL. A SHORT PHYSICIAN MODE RESET (PMR) WAS DONE AND THE POR WAS CLEARED. STIMULATION TURNED ON AND IT WAS NOTED TO BE WORKING ¿GOOD.¿ IT WAS FURTHER REPORTED THAT THERE WAS NO OBSERVABLE CODE THAT APPEARED WITH THE POR MESSAGE. IT WAS FURTHER STATED THAT THE PATIENT COULD NOT RECALL ANY EVENT OR CIRCUMSTANCE THAT CORRELATED WITH THE POR, INCLUDING ELECTROMAGNETIC INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539429 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR