BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3170982 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10413
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 24, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37092, LOT# 286830001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3550-39, LOT# N293954, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 355531, LOT# N294227, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: SCREENING. DEVICE PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-14, LOT# N294132, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-14, LOT# N283228, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S INS STOPPED WORKING SIX WEEKS AGO. THE PATIENT WAS LAST ABLE TO CHARGE THE INS SIX WEEKS AGO. IT WAS REPORTED THAT THE PATIENT WAS LOOKING FOR A NEW PAIN DOCTOR AND COULDN¿T SLEEP LAST NIGHT BECAUSE THE PAIN IN HIS LEG WAS SO BAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE PATIENT STOPPED FEELING STIMULATION SIX WEEKS AGO. IT WAS NOTED THAT THEY TRIED TO RECHARGE BUT IT WOULDN'T RECHARGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WORKED FOR THE PATIENT FOR QUITE A WHILE AND ¿THEN IT WENT DEAD AT HIS OWN FAULT BECAUSE HE MOVED.¿ THE PATIENT STATED THAT IT HAPPENED ¿YEAR BEFORE LAST ,¿ BUT THEN STATED IT WAS OVER A YEAR PRIOR TO THE REPORT. IT WAS NOTED THAT DUE TO THE IMPLANTABLE NEUROSTIMULATOR (INS) BEING DEAD, HE GOT THE INS RECHARGED BY THE MANUFACTURING REPRESENTATIVE OVER A YEAR PRIOR TO THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270560 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 00050 YR