BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 5240316 · Received November 20, 2015

    Report

    Report Number
    3004209178-2015-23221
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    October 28, 2015
    Report Date
    October 29, 2015
    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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 355024, LOT# N122858, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID 355024, LOT# N122858, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 39286-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 37713, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT A POWER-ON-RESET (POR) MESSAGE WAS SEEN ON THEIR PROGRAMMER AND THAT THE THERAPY FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) HAD STOPPED. THE PATIENT STATED THAT THEY HAD THE DEVICE OFF FOR A WEEK AND TURNED IT BACK ON THE DAY PRIOR TO REPORT. THEY CHARGED THE INS TO 3/4 FULL AND SAW THE POR MESSAGE. WITH ASSISTANCE FROM THE MANUFACTURER'S PATIENT'S SERVICES THE POR WAS ABLE TO BE CLEARED BY PRESSING THE SYNCH KEY ON THE PROGRAMMER, PRESSING ANY ARROW ON THE NAVIGATION BUTTON, AND THEN PRESSING THE SYNCH KEY AGAIN TO COMPLETE THE RESET. IT WAS THEN CONFIRMED THAT THE THERAPY WAS BACK ON AND THAT THE THERAPY WAS ADEQUATE. THE INDICATIONS FOR USE FOR THE IMPLANTED DEVICE WERE NOTED AS PERIPHERAL NEUROPATHY AND SPINAL PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770983 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR