BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2955110 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02516
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 29, 2013
    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: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE NEUROSTIMULATOR REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD ONLY CHARGE TO 50%. IT WAS NOTED THAT IMPEDANCES WERE NORMAL AND COUPLING WAS NORMAL AT 8 BARS. PATIENT WAS TAUGHT HOW TO USE THE SPACER ON THE BELT AND WAS TOLD TO SIT FOR A FEW HOURS. IT WAS LATER REPORTED THAT THE BATTERY SHOWED 50% AND IT "APPEARED THAT THE PATIENT WAS NOT CHARGING FOR MORE THAN A HALF HOUR, ALTHOUGH SHE WAS SITTING WITH THE CHARGER ON FOR 2 HOURS." THE MANUFACTURE REPRESENTATIVE REPORTEDLY MET WITH THE PATIENT "EVERY WEEK" FOR "SEVERAL WEEKS" TO TRY TO OPTIMIZE CHARGING. IT WAS STATED THAT THERE WERE 8 COUPLING BARS BUT AFTER 1.7 HOURS, THE BATTERY ONLY REACHED 75%. THE PATIENT REPORTEDLY "CAN ONLY CHARGE TO 50%;" IT WAS STATED THAT THE PATIENT WAS UNABLE TO GET 100% IN THE PAST MONTH. IMPEDANCES WERE STILL REPORTED AS "NORMAL." IT WAS NOTED THAT THE PATIENT HAD LIMITED NECK MOVEMENT AND RECEIVED INJECTIONS IN NECK ONCE A WEEK. LATER, IT WAS REPORTED THAT THE PATIENT NEEDED TO CHARGE EVERY DAY WHEREAS IN THE PAST, THE PATIENT CHARGED ABOUT ONCE A WEEK. PATIENT STILL REPORTED BEING UNABLE TO GET A 100% CHARGE. A RECHARGE INTERVAL CALCULATION INDICATED "ABOUT 3 DAYS." IMPEDANCES WERE REPORTEDLY ALL BETWEEN 400 AND 600 OHMS, BUT THE GROUP IMPEDANCE WAS ONLY 196 OHMS. AFTER REPROGRAMMING, THE RECHARGE INTERVAL WAS INCREASED TO 5 DAYS. IT WAS REPORTED A WEEK LATER THAT THE ISSUE "IMPROVED A BIT;" THE PATIENT REPORTEDLY WAS GETTING "AT LEAST A DAY AND A HALF OUT OF CHARGE." SEVERAL MONTHS LATER, IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED FOR PREMATURE BATTERY DEPLETION. IT WAS STATED THAT THE PATIENT WAS CHARGING HER DEVICE CORRECTLY AND THE HEALTHCARE PROVIDER (HCP) DECIDED IT WAS IN THE PATIENT'S BEST INTEREST TO REPLACE THE BATTERY. PATIENT REPORTEDLY WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58694 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 00053 YR Required Intervention