BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4814799 · Received June 3, 2015

    Report

    Report Number
    3004209178-2015-10176
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    May 10, 2015
    Report Date
    May 13, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97791, LOT# N358259, IMPLANTED: (B)(6) 2013, PRODUCT TYPE; ACCESSORY. PRODUCT ID: 39565-65, SERIAL# (B)(4) IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT TRIED TO CHARGE THE BATTERY HE WOULD GET 0 BOXES SHADED. HE HAD BEEN SCREWING WITH THE MACHINE FOR 3 DAYS. IT WAS NOTED THAT HE WAS IN THE HOSPITAL FOR TWO WEEKS FOR SURGERY, BUT IT WAS NOT RELATED TO THE IMPLANT. TROUBLESHOOTING WAS LIMITED AND THE PATIENT WANTED TO SPEAK WITH A MANUFACTURING REPRESENTATIVE (REP). IT WAS LATER REPORTED THAT THE PATIENT WOULD GO TO THE DOCTOR¿S OFFICE IF HE NEEDED AN INJECTION, BUT THEY HAD NOT SEEN HIM IN A WHILE. IT WAS NOTED THAT THIS DOCTOR WAS NOT THE IMPLANTING DOCTOR AND DID NOT MANAGE THE DEVICE. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360576 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR