BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3724236 · Received April 3, 2014

    Report

    Report Number
    3004209178-2014-05537
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 12, 2014
    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

    PRODUCT ID 74002, LOT# N202793, IMPLANTED: 2009 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3887-33, LOT# J0406107V, IMPLANTED: 2004 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3887-33, LOT# J0406107V, IMPLANTED: 2004 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STOPPED WORKING. THE PATIENT RECHARGED EVERY 4 DAYS AT THE TIME OF THE REPORT AND ORIGINALLY IT WAS AROUND EVERY 6 DAYS. ONE DAY THEY HAD RECHARGED THE NIGHT BEFORE AND THEN THEY FELT A SMALL SURGE, AND INCREASE IN STIMULATION WHICH WAS NOT PAINFUL AND THEN THEIR STIMULATOR TURNED OFF. WHEN THE PATIENT CHECKED THEIR DEVICE IT WAS COMPLETELY DISCHARGED AND WOULD NOT TURN ON. THE CHARGE WAS AT 0 AND THEY HAD TO CHARGE IT. THE DEVICE WAS CHECKED BY A MANUFACTURER REPRESENTATIVE A DAY PRIOR TO THE REPORT AND EVERYTHING WAS WORKING FINE. THE IMPEDANCES WERE IN A 600 TO 800 RANGE. THE PROBLEM HAD ONLY OCCURRED ONCE AND EVERYTHING WAS WORKING FINE SINCE THE ISSUE. CHARGING WAS FINE AND THE STIMULATION WAS FINE. IT WAS UNKNOWN IF THE PATIENT HAD ANY TYPE OF MEDICAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202475 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