BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4152876 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18536
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 19, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3776-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: (B)(6) 1994, PRODUCT TYPE: LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ¿SHUT DOWN FOR OVER AN HOUR AND WE COULDN¿T DO ANYTHING WITH THE CONTROLLER.¿ IT WAS ALSO REPORTED THAT THE PATIENT LAST CHARGED LAST WEEK AND JUST LOST STIMULATION THE DAY OF THE REPORT. IT WAS NOTED PATIENT WAS ¿FREEZING UP¿ ON HIS LEFT SIDE BECAUSE THE INS WOULDN¿T CHARGE OR TURN ON. THE ¿CHARGE YOUR INS¿ WARNING MESSAGE APPEARED. THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WOULDN¿T CHARGE THE INS AND THE PATIENT PROGRAMMER (PP) WAS NOT WORKING EITHER. THE PATIENT LOST 80 POUNDS AND THE IMPLANT WAS ¿UP TO THE TOP.¿ THE PATIENT WAS TALKING TO THE DOCTOR ABOUT REPLACEMENT. INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) THAT STATED THE CAUSE OF THE EVENT WAS DETERMINED BUT WAS NOT DEVICE RELATED AND NO REPROGRAMMING WAS NEEDED. THE CAUSE OF THE EVENT WAS A PHARMACOLOGIC SIDE EFFECT. TROUBLESHOOTING WAS PERFORMED ON (B)(6) 2014. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631104 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1