BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2894558 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00081
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377860, LOT# N0044934, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 377860, LOT# N0044934, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS STATED THAT A PATIENT WAS SEEING A WARNING POWER-ON-RESET (POR) SCREEN ON BOTH THE PROGRAMMER AND THE RECHARGER. THE PATIENT WAS AT THE DOCTOR OFFICE ON (B)(6) 2012 TO START A TRICKLE CHARGE. IT WAS STATED THAT THE BATTERY WAS FULLY CHARGED AND WAS GETTING THE POR SCREEN. THE PATIENT WAS AT THE DOCTOR'S OFFICE AT THE TIME OF THE REPORT. FURTHER INFORMATION WAS REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2830 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1