BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1970155 · Received January 14, 2011

    Report

    Report Number
    3004209178-2011-00387
    Event Type
    Injury
    Date Received
    January 14, 2011
    Report Date
    January 5, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD ATTEMPTED TO RECHARGE IN (B)(6) 2010 AND HAD NOT BEEN SUCCESSFUL. THERE WERE COUPLING/COMMUNICATION ISSUES. IT WAS POSSIBLE TO GET A READING IN THE 60'S USING THE ANTENNA LOCATOR FEATURE. IN (B)(6) 2010, THE STIMULATOR WAS OVERDISCHARGED AND IN A POWER-ON-RESET CONDITION. THE PT WAS ABLE TO GET THE DEVICE CHANGED UP TO A NORMAL CHARGING INTERFACE, BUT NOT MUCH AFTER THAT. ABOUT TWO WEEKS LATER, THERE WAS AGAIN NO TELEMETRY; THE STIMULATOR WAS OVERDISCHARGED. IT WAS NOT POSSIBLE TO BRING THE DEVICE OUT OF THE OVERDISCHARGE STATE THE SECOND TIME OR RETRIEVE ANY DATA FROM THE BATTERY. THE DEVICE WAS REPLACED. IT WAS FELT THE EVENT WAS DUE TO PT NON-COMPLIANCE WITH RECHARGING AND THE PHYSICIAN ELECTED NOT TO RETURN THE DEVICE TO THE MANUFACTURER FOR ANALYSIS. IT WAS STATED THE PT WAS DOING WELL FOLLOWING REPLACEMENT.

    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 Required Intervention PROGRAMMER: MODEL 37743, LOT# NKE100790N| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB016541N| ACCESSORY: MODEL 37752, LOT# NKA123733N| EXPLANTED:| LEAD: MODEL 3487A, LOT# V185448| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V130379| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3776, LOT# V183471027| IMPLANTED:| IMPLANTED: