BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1885269 · Received October 25, 2010

    Report

    Report Number
    3004209178-2010-08413
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MEDTRONIC 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

    IT WAS REPORTED ON (B)(6) 2010, THAT THE PATIENT'S INS RECHARGER SCREEN WAS UNRESPONSIVE. THE RECHARGER WAS TO BE RESET. IT WAS LATER REPORTED, ON (B)(6) 2010, THAT THERE WAS A "XXX" READING FOR IMPEDANCE AND AMPLITUDE LEVELS. IT WAS SUGGESTED THAT THIS INDICATED A POSSIBLE SHORT CIRCUIT. THE PATIENT REPORTED NOT FEELING DEVICE STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE MANUFACTURER REPRESENTATIVE WAS NOT ABLE TO RESET THE RECHARGER. THE PATIENT WAS, THUS, NOT ABLE TO RECEIVE STIMULATION. THE PATIENT OPTED TO NOT DO ANYTHING ELSE REGARDING THE STIMULATION. NO FURTHER DETAILS OR PATIENT OUTCOME WERE PROVIDED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 69 YR EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE136581N| LEAD: MODEL 3778, LOT# V133843002| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA133384N| LEAD: MODEL 3778, LOT# V055164023| EXPLANTED:| IMPLANTED:| EXPLANTED: