BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1890976 · Received October 29, 2010

    Report

    Report Number
    3004209178-2010-08667
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 6, 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
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN MAY THAT THE RECHARGE ANTENNA GOT HOT WHEN RECHARGING. THE PT WAS INSTRUCTED REGARDING THE USE OF COOL TOWELS, SPACERS, AND STOPPING THE RECHARGING AND TRYING AGAIN. IN (B)(6), IT WAS REPORTED THAT THE PT EXPERIENCED SHOCKING IN THE BACK. TROUBLESHOOTING WAS PERFORMED, BUT THE PT STILL FELT SHOCKS AS THE VOLTAGE INCREASED. THIS HAPPENED WHEN EACH LEAD WAS TESTED SEPARATELY. THE PT WAS NOT GETTING THERAPEUTIC RELIEF. IMPEDANCE READINGS WERE NORMAL. IT ALSO AGAIN WAS INDICATED THAT THE ANTENNA GOT HOT WHEN CHARGING. THE PT PLANNED TO SEE THE HEALTH CARE PROFESSIONAL THE FOLLOWING DAY. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO 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 39 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE128108N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V185702005| IMPLANTED:| LEAD: MODEL 3778, LOT# V262581030| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA127963N