BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2918737 · Received January 16, 2013

    Report

    Report Number
    3004209178-2013-00667
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Report Date
    December 26, 2012
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377675, LOT # V002688, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37082-40, SERIAL # (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-45, LOT # V103837, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT # V103837, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WAS WORKING WITH THEIR DOCTOR OR COMPANY REPRESENTATIVE. AN APPOINTMENT WAS SCHEDULED FOR (B)(6) 2013. ABOUT TWO WEEKS LATER ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THERE WERE NO ABNORMAL IMPEDANCES MEASURED. THE CHARGING ISSUE WAS THAT THE PATIENT WAS CHARGING MORE FREQUENTLY. THE FREQUENCY WAS AT 260 HZ. THE DEVICE WAS RE-PROGRAMMED TO A LOWER FREQUENCY. THE PATIENT WAS GOING TO FOLLOW UP WITH THE HCP IN ONE MONTH. RE-PROGRAMMING HAPPENED ON (B)(6) 2013. PATIENT HOSPITALIZATION WAS NOT REQUIRED AND THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT HOLDING A CHARGE THE WAY IT USED TO. THE PATIENT WAS PREVIOUSLY ABLE TO GO FOR TWO WEEKS WITHOUT CHARGING BUT IT HAD GOTTEN TO WHERE THE PATIENT NEEDED TO CHARGE EVERY 2-3 DAYS. THE LAST TIME THE PATIENT CHARGED HIS DEVICE WAS ON (B)(6) 2012 AND ON THE DAY OF THE REPORT, THE PATIENT HAD TO CHARGE IT AGAIN. THE REPORTER INDICATED THAT THIS HAD "SLOWLY GOTTEN WORSE" WITHIN THE 6 MONTHS PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT CHARGED HIS DEVICE UNTIL HE SAW THE "CHARGE COMPLETE" ICON. THE REPORTER ALSO STATED THAT THE PATIENT HAD HIS DEVICE REPROGRAMMED SEVERAL MONTHS PRIOR TO THE REPORT. IT WAS INDICATED THAT THE PATIENT USED STIMULATION 24 HOURS A DAY AND HAD NOT MADE ANY ADJUSTMENTS WITH HIS PROGRAMMER. INS BATTERY DEPLETION WAS SUSPECTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24381 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