BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3202747 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11205
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    July 9, 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 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37743 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. THERE WAS A CONFIRMED OVERDISCHARGE. THE PATIENT STATED, SHE NEVER RECEIVED THERAPY THE WAY SHE HAD DURING THE TRIAL. THE PATIENT GAVE UP ON THE SYSTEM. PATIENT NON-COMPLIANCE WAS INVOLVED, THE PATIENT DID NOT USE DEVICE NOR DID THEY MAINTAIN CHARGE. IT WAS NOTED PATIENT WAS CONSIDERING REPLACEMENT OF RECHARGEABLE DEVICE WITH A NON-RECHARGEABLE DEVICE WITH NEW PROGRAMMING IN ORDER TO EXPERIENCE THERAPY IN THE AREAS OF PAIN. THERE WERE NO PATIENT SYMPTOMS RELATED TO THIS EVENT. ADDITIONAL INFORMATION REQUESTED, BUT HAD NOT BEEN AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WANTED TO THINK ABOUT HAVING THE DEVICE REPLACED OR REMOVED AND THE DECISION WAS STILL PENDING. PATIENT WAS NOT RECEIVING THERAPY AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300995 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