BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2171049 · Received June 30, 2011

    Report

    Report Number
    3004209178-2011-04972
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    August 1, 2009
    Report Date
    June 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN (B)(6) 2009, THAT THE PT RECEIVED NO STIMULATION SENSATION. THE PT'S RECHARGER WOULD NOT REMAIN TURNED ON IN ORDER TO CHARGE THE DEVICE. IT WAS LATER REPORTED, IN (B)(6) 2010, THAT THE PT WAS UNABLE TO ADJUST THE STIMULATION, AND RECEIVED NO STIMULATION SENSATION. WHEN ATTEMPTING TO RECHARGE, THE DEVICE "WOULD NOT DO ANYTHING." BOTH THE PT'S RECHARGER AND PROGRAMMER DISPLAYED A MESSAGE TO REPOSITION THE ANTENNA OVER THE NEUROSTIMULATOR. A NEUROSTIMULATOR OVERDISCHARGE WAS SUSPECTED. WHEN THE STIMULATION STOPPED WORKING, THE PT EXPERIENCED A "CRIPPLING" RETURN OF SYMPTOMS DUE TO RIGHT-SIDE NERVE DAMAGE. THE PT'S ARM TURNED PURPLE AND A CHANGE IN GAIT WAS EXPERIENCED. WHEN THE PT GAINED WEIGHT, THE SKIN FELT "TAUT AROUND THE WIRE," LIKE IT WAS "PUSHING OUT WITH A PRESSURE FEELING." THE PT'S DEVICE WAS DETERMINED TO BE OVERDISCHARGED, BUT WAS CHARGED BY THE MFR REP. THE PT WAS "DOING WELL" AND CHARGING WAS EASIER. IT WAS REPORTED IN (B)(6) 2011, THAT THE PT'S NEUROSTIMULATOR WAS OVERDISCHARGED. THE DEVICE WAS CHARGED. UPON INTERROGATION, THE DEVICE DISPLAYED AN END OF SVC/END OF LIFE (EOS/EOL) MESSAGE. IT WAS NOTED THAT THE PT ENCOUNTERED PREVIOUS DEVICE OVERDISCHARGES. THE CAUSE OF THE OVERDISCHARGE WAS UNCLEAR. THE PT WAS TO HAVE A BATTERY REPLACEMENT AND POSSIBLE LEAD REVISION, BUT WAS NOT SCHEDULED FOR THE PROCEDURE AS OF THE DATE OF THIS REPORT. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE120550N| EXTENSION: MODEL 37082, LOT# NKC004920N| RECHARGER: MODEL 37752, LOT# NKA122471N| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC004965N| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# J0564099V