BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3118879 · Received May 19, 2013

    Report

    Report Number
    3004209178-2013-07846
    Event Type
    Malfunction
    Date Received
    May 19, 2013
    Report Date
    April 30, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A-33, LOT# V160153, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT# V152707, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE TELEMETRY ISSUES AND A POWER-ON-RESET (POR) MESSAGE ON THE PROGRAMMER AND RECHARGER. THE EVENT OCCURRED ABOUT TWO WEEKS PRIOR TO REPORT. THE PATIENT INDICATED HIS DEVICE HAD NOT BEEN OVERDISCHARGED AND A PHYSICIAN-MODE-RECHARGE (PMR) HAD NOT BEEN DONE. HOWEVER, UPON INTERROGATION THE CLINICIAN PROGRAMMER ¿STATED¿ OVERDISCHARGE AND THE CLOCK NEEDED TO BE RE-SYNCHED. NO ERROR CODE HAD BEEN OBSERVED. THE POR WAS CLEARED AND THE PATIENT RETURNED TO NORMAL FUNCTIONING STATUS WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220778 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