BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3965241 · Received July 29, 2014

    Report

    Report Number
    3004209178-2014-13648
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    May 20, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3487A-45, LOT# V132933, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3487A-45, LOT# V132933, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL # (B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS STILL IMPLANTED BUT WAS OUT OF SERVICE. THE PATIENT REPORTED A DEAD BATTERY. THE PATIENT HAD NOT BEEN SEEN IN THE CLINIC IN OVER 3 YEARS. THE BATTERY HAD BEEN DEAD FOR WELL OVER A YEAR AND POSSIBLY TWO YEARS DUE TO THE PATIENT NOT USING SINCE THEY WERE UNDERGOING TREATMENT FOR CANCER. THE PATIENT MET WITH A MANUFACTURER REPRESENTATIVE IN (B)(6) THEY THOUGHT AND THEY ATTEMPTED PHYSICIAN MODE RECHARGES FOR 4-5 HOURS WITHOUT SUCCESS. AN OVERDISCHARGE WAS CONFIRMED BUT IT WAS UNKNOWN WHAT NUMBER OVERDISCHARGE IT WAS. THE PATIENT WANTED THEIR DEVICE REPLACED. A REPLACEMENT WAS BEING PLANNED FOR (B)(6). THE CAUSE OF THE ISSUE WAS PATIENT NON-COMPLIANCE. WHEN THE PATIENT LAST USED THEIR DEVICE IT COVERED THEIR PAINFUL AREAS AND OFFERED GOOD PAIN RELIEF. THE PATIENT HAD A LOSS OF USE OF THEIR DEVICE. THE PATIENT STATUS WAS LISTED AS ALIVE WITH NO INJURY. IT WAS FURTHER REPORTED THAT 3 PHYSICIAN MODE RECHARGES WERE ATTEMPTED AND THERE WAS NO RESPONSE FROM THE DEVICE AT ALL. THE PATIENT PREFERRED HAVING A REPLACEMENT RATHER THAN CONTINUING TO TRY AND RESET THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED ON 2014-(B)(6) AND THEY WERE PROGRAMMED WITH SEVERAL GROUPS THAT COVERED ALL PAINFUL AREAS. THE PATIENT SAID IT FELT AMAZING AND WAS VERY EXCITED TO HAVE STIMULATION AGAIN AND SAID THE RELIEF WAS INSTANT. THE PATIENT WAS INSTRUCTED ON THE IMPORTANCE OF KEEPING THE DEVICE CHARGED EVEN IF NOT USED FOR EXTENDED PERIODS AND THE PATIENT VERBALIZED UNDERSTANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441933 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 Required Intervention