BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 5612460 · Received April 27, 2016

    Report

    Report Number
    3004209178-2016-08398
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    April 3, 2016
    Report Date
    April 27, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PATIENT REPORTED VIA COMPANY REPRESENTATIVE (REP) ON (B)(6) 2016 STATING THAT THERE WAS AN OVERDISCHARGE. COMMUNICATION WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS POSSIBLE AFTER THE REP CONDUCTED A PHYSICIAN MODE RECHARGE (PMR), AND A POWER ON RESET (POR) MESSAGE WAS DISPLAYED. THE REP HAD LED THE INS CHARGE TO HALF, AND THE BATTERY DISCHARGED UPON INTERROGATION. THIS ALSO OCCURRED AFTER THE PATIENT HAD CHARGED TO 3/4. THE LAST SUCCESSFUL RECHARGE WAS (B)(6) 2015. THE PATIENT HAD LOST WEIGHT AND DIDN'T NEED THEIR SPINAL CORD STIMULATION (SCS). THEY ALSO STATED THAT THE PATIENT HAD A LACK OF TRAINING. THE REP WAS GOING TO CHARGE THE PATIENT'S INS FULLY AND ATTEMPT TO CLEAR THE POR. THE ISSUES HAD OCCURRED THE DAY PRIOR TO REPORT. THE REP CALLED BACK FOUR DAYS LATER STATING THAT THEY WERE LATER ABLE TO INTERROGATE THE INS TO SEE A 0X800 POR MESSAGE. THEY WERE ABLE TO CLEAR THE POR. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON (B)(6) STATING THAT THE POR WAS CLEARED AND THEY WERE MEETING WITH THE PATIENT TWO DAYS LATER TO SEE IF THEIR STIMULATION NEEDED TO BE PROGRAMMED. THERE WERE NO RELATED PATIENT SYMPTOMS REPORTED, AND THE INDICATIONS FOR USE WERE SPINAL PAIN AND EPIDURAL FIBROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267542 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 46 YR