BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1081281 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04309
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT TURNED THE DEVICE OFF DURING INTERCOURSE. THE PT TURNED THE DEVICE BACK ON AND WITHIN 10 MINUTES EXPERIENCED A SHOCKING SENSATION ALL OVER HIS BODY. THE PT TURNED OFF THE DEVICE, BECAUSE HE DIDN'T WANT TO "GET SHOCKED AGAIN". THE INS HAD BEEN DISCHARGED SINCE THE SHOCKING INCIDENT. THE PT RECHARGED THE DEVICE FOR 5 HOURS AND THE DEVICE WAS 1/3 FULL. WHEN THE MANUFACTURER'S REP MET WITH THE PT FOLLOWING THE RECHARGE, THE BATTERY WAS THEN DEPLETED AND THE REP WAS UNABLE TO PROGRAM THE DEVICE. THE PT REPORTED HE HAD BEEN ABLE TO CHARGE AND TURN ON THE DEVICE WITH NORMAL STIMULATION EARLIER IN THE WEEK. IMPEDANCES WERE CHECKED AND ALL FOUND TO BE WITHIN NORMAL RANGES. THE DEVICE REMAINS IMPLANTED AND THE PT WILL CONTINUE TO USE THE DEVICE AS NORMAL. UPON FOLLOW UP, THE HCP STATED, "HE [THE PT] WAS FINE". ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3778 LOT# V073572008| IMPLANTED:| IMPLANTED:| LEAD MODEL 3778 LOT# V046559024| EXPLANTED:| EXPLANTED: