BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2211149 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06142
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NOT FEELING A STIMULATION SENSATION AND WAS NOT ABLE TO COMMUNICATE WITH HIS NEUROSTIMULATOR. THE PT HAD TO RECHARGE DAILY AS THE BATTERY WAS DRAINING DAILY. THE PT MET WITH A MFR REP ON (B)(6) 2011. AT THAT TIME, THE NEUROSTIMULATOR WAS IN AN OVERDISCHARGED STATE AND TELEMETRY WAS NOT POSSIBLE. THE PT DID NOT BRING HIS EQUIPMENT TO THE APPOINTMENT, AND WAS GOING TO BE SEEN AGAIN THE WEEK OF (B)(6) 2011. NO INTERVENTIONS TOOK PLACE. THE PT STATED LEAD COVERAGE PROVIDED ACCEPTABLE PARESTHESIA, BUT WAS NOT SATISFIED WITH RECHARGING AND WANTED A NON-RECHARGEABLE DEVICE. AN APPOINTMENT WAS GOING TO BE SCHEDULED TO REPLACE THE NEUROSTIMULATOR. THE DEVICE WAS IN ITS THIRD OVERDISCHARGED STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR ACCESSORY: MODEL 37752, LOT# NKA116836N| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE120935N| LEAD: MODEL 3778, LOT# V051862011| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V028772023