BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1231039 · Received October 30, 2008

    Report

    Report Number
    3004209178-2008-07030
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THAT THE IMPLANT BIT WAS SET PREMATURELY ON (B)(6) 2008 THEN THE DEVICE SAT IDLE UNTIL (B)(6) 2008 WHERE IT WENT INTO LOCK MODE.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE IMPLANTABLE NEUROSTIMULATOR WOULD NOT CHARGE IN THE OPERATING ROOM, POSSIBLY DUE TO TELEMETRY ISSUES CAUSED BY ELECTRO-MAGNETIC INFERENCE. THE HCP OPTED TO IMPLANT A DIFFERENT NEUROSTIMULATOR. THE DEVICE WAS REMOVED FROM THE OPERATING ROOM ENVIRONMENT. THERE WERE CONTINUED RECHARGING ISSUES. THE RECHARGER WAS LEFT ON THE DEVICE AND APPROX 20 TO 30 MINUTES LATER, IT DID BEGIN TO RECHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1