BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5840066 · Received August 2, 2016

    Report

    Report Number
    3004209178-2016-15355
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    June 1, 2016
    Report Date
    August 2, 2016
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37761 LOT# SERIAL (B)(4) PRODUCT TYPE RECHARGER. UNDER ANALYSIS IT WAS CONFIRMED THAT THE DESKTOP CHARGER CABLE WAS FRAYED. THE CONCLUSION CODE (B)(4) APPLIES TO THE INS AND THE CONCLUSION CODE (B)(4) APPLIES TO THE DESKTOP CHARGER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A FAMILY MEMBER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR POST LUMBAR LAMINECTOMY SYNDROME. IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN ABLE TO CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS) AND WAS GETTING WHAT THEY THOUGHT WAS THE REPOSITION ANTENNA SCREEN. THE CALLER DID NOT KNOW THE LAST TIME THAT THE PATIENT FELT STIMULATION. THE PATIENT HAD SOME ISSUES WITH THE DESKTOP CHARGER CORD. THE CALLER HAD CONTACTED A MANUFACTURER REPRESENTATIVE JUST PRIOR TO CALLING THE MANUFACTURER AND WAS TOLD BY THE MANUFACTURER REPRESENTATIVE THAT THE PATIENT SHOULD GET A NEW DESKTOP CHARGER BEFORE DOING ANY TROUBLESHOOTING. THE DESKTOP CHARGER CORD WAS DAMAGED AND THE CALLER SAW SEPARATION OF RUBBER BY THE METAL CONNECTOR PIN AND BY THE POWER PACK. THE METAL CONNECTOR PIN "MIGHT BE A LITTLE BENT." THE CORD WIRES WERE EXPOSED BUT NOT FRAYED. IT WAS LATER STATED THAT THE DESKTOP CHARGER CABLE WAS FRAYED. THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WAS NOT CHARGING AND WAS NOT WORKING AS THE CALLER STATED THAT THEY SAW SOME ERRORS ON THE SCREEN. THE PLUG IN ICON WAS SEEN. THESE ISSUES WERE STATED TO HAVE STARTED IN (B)(6) 2016 OR LONGER. THE EVENT DATE WAS NOT ABLE TO BE CLARIFIED BY THE CALLER. A PHONE CALL WITH THE PATIENT'S FAMILY MEMBER WAS MADE ON (B)(6) 2016. THE FAMILY MEMBER STATED THAT THEY HAD RECEIVED THE NEW DESKTOP CHARGER AND THEY HAD BEEN ABLE TO CHARGE UP THE RECHARGE. THEY WERE UNABLE TO CHARGE THE IMPLANTED STIMULATOR. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2016 TO MEET WITH SOMEONE AT THE HEALTH CARE PROFESSIONAL (HCP) OFFICE TO "GET IT STARTED AGAIN." THE CALLER DID NOT KNOW THE NAME OF THE MANUFACTURER REPRESENTATIVE WHO WAS GOING TO BE AT THE APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493395 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 55 YR