BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 5059734 · Received September 7, 2015

    Report

    Report Number
    3004209178-2015-17405
    Event Type
    Malfunction
    Date Received
    September 7, 2015
    Report Date
    August 13, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3487A-56, LOT# V634065, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V747151, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# V882270, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V687756, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER VIA A MANUFACTURING REPRESENTATIVE (REP) REPORTED THAT THE PATIENT'S BATTERY WAS OVERDISCHARGED. THE PATIENT WAS NOT GETTING GOOD COVERAGE ANY MORE. THERE WAS RIB AND STOMACH STIMULATION, SO THE PATIENT STOPPED USING AND CHARGING THE DEVICE BECAUSE IT WAS NOT WORKING. TROUBLESHOOTING WAS PERFORMED BY CHARGING THE BATTERY AND THE POWER ON RESET (POR) WAS CLEARED. THE BATTERY WAS CHARGED TO 25% AND THE PATIENT WAS REPROGRAMMED. THE REP WAS UNABLE TO GET LOW BACK COVERAGE WITH RIB STIMULATION. THE STIMULATION DID CAPTURE BUTTOCKS, HIPS, AND DOWN THE LEG. THE PATIENT HAD SOME HIP AND LEG PAIN. THE DOCTOR AND THE PATIENT DISCUSSED THE PROBLEM AND DECIDED TO LET THE PATIENT DECIDE IF THEY WERE OKAY WITH NO STIMULATION IN THE LOW BACK OR A REVISION/EXPLANT WAS NEEDED. THEY WOULD FOLLOW UP IN 1 MONTH. THE PATIENT LEFT WITH GOOD COVERAGE IN HER HIPS AND LEGS. THE PATIENT WAS EDUCATED ABOUT THE RECHARGING PROCESS. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT. NO SURGICAL INTERVENTION OCCURRED AND IT WAS UNKNOWN IF ANY INTERVENTION WAS PLANNED. IT WAS NOTED THAT THE PATIENT WAS IMPLANTED FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. NO INTERVENTION S OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP) LATER REPORTED THAT THEY HAD NOT SEEN OR HEARD FROM THE PATIENT. THE REP WAS ASSUMING THE PATIENT WAS STILL USING THE NEW PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590900 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1