BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4232677 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21082
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708320, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3708320, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-33, LOT# J0337579V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET (POR) CONDITION OCCURRED. THE PATIENT REPORTED TO THE COMPANY REPRESENTATIVE THAT THEY GOT A POR CODE ON THE RECHARGER. IT WAS REPORTED TO NOT BE RELATED TO OVERDISCHARGE. THE PATIENT THINKS THAT THEY ALSO SAW AN ELECTIVE REPLACEMENT INDICATOR (ERI). AS THE PATIENT SAID THEIR BATTERY WAS NEARING END OF LIFE. IT WAS NOTED THAT THE PATIENT IS STILL ABLE TO USE THEIR STIMULATOR BUT MADE AN APPOINTMENT TO WITH THE PHYSICIAN TO DISCUSS REPLACEMENT. THE APPOINTMENT WAS SCHEDULED FOR (B)(6) 2014. NO SYMPTOMS WERE REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713156 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR