BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2181476 · Received July 5, 2011

    Report

    Report Number
    3004209178-2011-05064
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD NOT CHANGED, OR USED THE STIMULATION, FOR SEVERAL MONTHS AND EXPERIENCED TELEMETRY ISSUES AND NO COMMUNICATION BETWEEN THE IMPLANTABLE NEUROSTIMULATOR AND THE PROGRAMMER. A DEVICE OVER-DISCHARGE WAS SUSPECTED. THE PT WAS SCHEDULED TO SEE THE PHYSICIAN. IT WAS LATER REPORTED THAT IT WAS NOT POSSIBLE TO BRING THE PT'S DEVICE OUT OF OVER-DISCHARGE AFTER MAKING THREE ATTEMPTS USING A PHYSICIAN MODE RECHARGE (PMR). THE OVER-DISCHARGE WAS NOT CONFIRMED. THE DEVICE WAS REPOSITIONED. THE PT REQUESTED THAT THE DEVICE BE REPLACED WITH A NON-RECHARGEABLE NEUROSTIMULATOR. A REPLACEMENT SURGERY HAD NOT BEEN SCHEDULED. NO FURTHER DETAILS REGARDING PT SYMPTOMS OR OUTCOME WERE PROVIDED. A F/U REPORT WILL BE FILED IF ADDITIONAL 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 48 YR LEAD: MODEL 3998, LOT# V111320| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB008771N| PROGRAMMER: MODEL 37743, LOT# NKE 101246N| EXPLANTED:| RECHARGER: MODEL 37752, LOT# NKA110984N