BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3934828 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13016
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 23, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-33, LOT# V483090, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3888-45, LOT# V508213, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3888-45, LOT# V508213, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3888-33, LOT# V483090, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE OF >10,000 OHMS ON ELECTRODE 3. THE PATIENT HAD A SHOCKING AND JOLTING SENSATION AND STIMULATION IN THE WRONG LOCATION. IMPEDANCE TESTING WAS DONE AND A REPROGRAMMING WAS PERFORMED. THE PATIENT ALSO HAD A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. THE PATIENT HAD PAIN AND LESS THAN 50% THERAPY RELIEF AT THE LEAD LOCATION. FOLLOWING AN INJECTION THE PATIENT HAD PAIN SHOOTING DOWN THEIR SIDE AND UNCOMFORTABLE STIMULATION. IT WAS FURTHER REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. REPROGRAMMING WAS PERFORMED ON (B)(6). THEY WERE ABLE TO AVOID ANY PAINFUL SENSATIONS AND REGAIN COVERAGE AFTER THE REPROGRAMMING. AT THE TIME OF THE REPORT THE PATIENT HAD REGAINED COVERAGE AND WAS NOT FEELING ANY PAINFUL SENSATIONS. 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
    413903 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