BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3193640 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10978
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 6, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3550-39, LOT# N288731, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3550-29, LOT# N284516, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S RECHARGER WAS WORKING OK BUT WAS CONCERNED ABOUT HOW OFTEN SHE WAS CHARGING. IT WAS NOTED THAT THE PATIENT FELT THE BATTERY WAS DEPLETING QUICKLY BECAUSE SHE CHARGED EVERY DAY FOR A COUPLE OF HOURS. IT WAS FURTHER NOTED THAT THE PATIENT STARTED TO HAVE SYMPTOMS ON HER RIGHT SIDE AND WOULD LIKE A SECOND LEAD PLACED. IT WAS ALSO STATED THAT THE PATIENT HAD NEW PAIN IN HER RIGHT HAND AND ARM. IT WAS ADDITIONALLY REPORTED THAT IT WAS ATTEMPTED TO REPROGRAM THE PATIENT'S BATTERY TO USE LESS BATTERY CONSUMPTION BUT WAS UNABLE TO. IT WAS ALSO NOTED THAT THE PATIENT WILL HAVE HER BATTERY REPLACED, WITH THE POSSIBILITY OF ADDING ANOTHER LEAD, AND THE SURGERY WAS SCHEDULED FOR EARLY AUGUST. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S SURGERY WAS SCHEDULED FOR (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A NEW LEAD WAS ADDED FOR RIGHT ARM COVERAGE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THE REVISION (B)(6)2013. IT WAS NOTED THAT THE PATIENT NOW GOT STIMULATION ON THE RIGHT AS THE PATIENT NEEDED. IT WAS NOTED THAT A BIGGER BATTERY WAS USED TO GET MORE TIME BETWEEN CHARGES AND IT ALREADY HELPED. IT WAS NOTED THAT THE PATIENT WAS PLEASED WITH THE OUTCOME SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294720 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