BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3133482 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08248
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 3, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37082-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT # V185950, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS NOT MAINTAINING A CHARGE. IT WAS NOTED THAT THE PATIENT WAS AT 50% EVEN THOUGH SHE HAD BEEN CHARGING THE LAST 3 DAYS, BUT WAS THEN AT 25%. AFTER TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT HAD BEEN RECHARGING, BUT WAS ONLY GETTING 2 COUPLING BARS WHILE STILL USING STIMULATION. IT WAS NOTED THAT THE PATIENT MOST LIKELY WAS USING MORE THAN SHE WAS ABLE TO RECHARGE. THE REPORTER NOTED THAT THE PATIENT STARTED HAVING TROUBLE WITH COUPLING ABOUT 7-8 MONTHS PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT HAD TO PUT PRESSURE ON THE IMPLANT SITE TO GET COUPLING, BUT IT CAUSED PAIN. IT WAS NOTED THAT THIS ISSUE STARTED IN (B)(6) 2013. THE PATIENT STATED THAT THE INS HAD ¿ALWAYS MOVED AROUND¿ SINCE IMPLANTATION. IT WAS NOTED THAT SHE WAS HAVING MORE ¿STABBING PAIN¿ AT THE LEAD SITE AND ¿STICKING PAIN¿ AT THE SPINE FOR ABOUT A YEAR THAT WAS ¿COMING AND GOING.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY. ADDITIONAL INFORMATION WAS REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD HARDLY WALK FOR 3 OR 4 DAYS AFTER SITTING FOR A FULL RECHARGE BECAUSE IT HURT THEM SO BAD. THE PATIENT DIDN¿T THINK THAT THEIR BATTERY SHOULD HAVE LOST HALF A CHARGE IN 3 DAYS BECAUSE THEY HAD BEEN RECHARGING THEIR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234578 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