BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3781992 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08319
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 25, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37791, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS OF THE STIMULATOR REVEALED NO SIGNIFICANT ANOMALIES.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED A WARM SENSATION IN OR AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET DURING RECHARGING. IT WAS RECOMMENDED THAT THE PATIENT ADD A LAYER OF INSULATION MATERIAL BETWEEN THE CHARGE ANTENNA AND SKIN. IT WAS NOTED THAT THE PATIENT HAD CONCERNS ABOUT WEIGHT GAIN AND ONLY GETTING FOUR BARS. IT WAS NOTED THAT THE PATIENT WAS GETTING A THERMOMETER SCREEN ON THEIR RECHARGER. IT WAS NOTED THAT THE PATIENT WAS HAVING TROUBLE GETTING COUPLING. IT WAS THEN REPORTED THE PATIENT EXPERIENCED A TEMPERATURE MESSAGE AND WAS UNABLE TO CHARGE ANY LONGER. IT WAS NOTED THAT THIS OCCURRED AFTER ONE HOUR OF RECHARGING. IT WAS NOTED THAT THE PATIENT HAS GAINED APPROXIMATELY 10 POUND. IT WAS FURTHER NOTED THAT THE PATIENT HAD GAINED 20 POUNDS AND THEN LOST 10 POUNDS. IT WAS NOTED THAT THE PATIENT RECHARGED EVERY COUPLE OF DAYS. INTERROGATION WITH A CLINICIAN PROGRAMMER INDICATED THAT THE PATIENT CHARGED EVERY TWO TO THREE DAYS FOR 2.5 HOURS. IT WAS NOTED THAT IMPEDANCES WERE MEASURED; A1 WAS AT 359 OHMS AND A2 WAS AT 794 OHMS WHEN TESTING AT 4 VOLTS AND A PULSE WITH OF 450 AND A RATE OF 40. IT WAS NOTED THAT THE PATIENT STATED SHE ONLY GOT TO 50% WHEN SHE RECEIVED THE OVERTEMPERATURE MESSAGE. IT WAS NOTED THAT THE PATIENT COULD ONLY EVER GET TO 50% CHARGED BEFORE THE MESSAGE CAME UP. IT WAS FURTHER REPORTED THAT THE PATIENT HAD THE DEVICE EXPLANTED AND REPLACED DUE TO THE RECHARGING ISSUES AND THE THERMOMETER MESSAGE. TROUBLESHOOTING HAD BEEN DONE BY MULTIPLE COMPANY REPRESENTATIVES. IT WAS STATED THAT THE BATTERY APPEARED TO BE TILTED IN THE LEFT FLANK. WHEN THE DEVICE WAS REPLACED, IT WAS REPOSITIONED. AFTER THE REPLACEMENT, THE COMPANY REPRESENTATIVE WAS ABLE TO GET 6 BARS WHILE THE PATIENT WAS PRONE ON THE TABLE. THE PATIENT'S STATUS WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260678 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 00073 YR Required Intervention