BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1884632 · Received October 19, 2010

    Report

    Report Number
    3004209178-2010-08093
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 21, 2010
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED COUPLING AND OR COMMUNICATION ISSUES. IT WAS NOTED SECOND PHYSICIAN RECHARGE MODE HAD BEEN INITIATED. IT WAS NOTED PROBLEMS WITH RECHARGE COUPLING WERE PRIMARY REASON FOR OVER DISCHARGE. HOWEVER, PT HAD BEEN WITHOUT STIMULATION FOR UNDETERMINED TIME. COUPLING ISSUE MAY BE DUE TO OVER DISCHARGED FOR A LENGTHY DURATION. IT WAS ALSO REPORTED TELEMETRY ISSUES OCCURRED. AN IMPLANTABLE NEURO STIMULATOR (INS) OVER DISCHARGE WAS SUSPECTED. IT WAS UNSURE HOW MANY MONTHS SINCE LAST CHARGE, BUT SEVERAL MONTHS. IT WAS NOTED BEING UNABLE TO COMMUNICATE WITH DEVICE, INS RECHARGER, AND PT PROGRAMMER. IT WAS LATER REPORTED THEY CHANGED OUT AN ULTRA BATTERY FOR A RESTORE PRIME BECAUSE THE PT SAID SHE COULD NOT RECHARGE THE ULTRA. THEY HAD MET WITH THE PT ON TWO SEPARATE OCCASIONS TO HELP WITH RECHARGING. ALTHOUGH THE BATTERY WAS PALPABLE, IT SEEMED A LITTLE DIFFICULT TO MAINTAIN A FULL SIGNAL. PT WAS TOLD TO GO HOME AND TRICKLE CHARGE BATTERY. THE PT KEPT SAYING THE BATTERY DOES NOT WORK AND WANTED A NON RECHARGEABLE. COMPANY REP NOTED PT HAD DEVICE REPLACED DUE TO DIFFICULTY RECHARGING. COMPANY REP PROGRAMMED THE NEW BATTERY AND THE PT GOT GOOD STIMULATION. PT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION WILL BE PROVIDED WHEN IT 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 55 YR Required Intervention ACCESSORY: MODEL 37752, LOT# NKA129673N| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE131710N| EXPLANTED:| LEAD: MODEL 39565-65, LOT# N210152002| EXPLANTED:| IMPLANTED: