BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVNACED RECHARGEABLE

    MDR report key: 1744496 · Received June 30, 2010

    Report

    Report Number
    3004209178-2010-05143
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    March 1, 2010
    Report Date
    June 2, 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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PATIENT STATES STIMULATION IS INTERMITTENT. ACCORDING TO THE PATIENT PROGRAMMER, STIMULATION IS ALWAYS ON. HE SAID THERE ARE PERIODS OF TIME WHERE HE DOESN'T FEEL STIMULATION UNTIL HE ADJUSTS THE PARAMETERS. DEVICE IS NORMALLY AT 3.20V. THE RECHARGE INTERVAL HAS INCREASED WITH THIS NEW SYSTEM. OLD SYSTEM AVERAGED FROM 20-25 AND NEW SYSTEM IS 30-40 DAYS. REPORTS COUPLING IS GOOD AND RECHARGES IN AN AVERAGE OF 3 HOURS WHEN THE BATTERY IS 1/4 FULL. HISTORY OF PAST RECHARGE SESSIONS: (B)(6)2009 -- 39 DAYS, (B)(6)2010 -- 32 DAYS, (B)(6)2010 -- 22 DAYS, (B)(6)2010 -- 33 DAYS AND (B)(6)2010 -- 55 DAYS. PATIENT STATES HE USED TO BE ABLE TO WALK NINE HOLES OF GOLF BUT NOW IS NOT ABLE TO DUE TO THE PAIN. PATIENT WILL KEEP A HISTORY OF THE STIMULATION ON/OFF AND ACTIVITY AT THE TIME TO DETERMINE IF RECHARGING INTERVALS ARE APPROPRIATE. MEDTRONIC REPRESENTATIVE REPORTS AT THE LAST INS INTERROGATION, TWO CONTACTS HAD >10,000 OHMS AND SHE WAS ABLE TO CHANGE THE PROGRAM TO REMOVE THOSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVNACED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA123723N| PROGRAMMER: MODEL 37743, LOT# NKE119993N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3776, LOT# V006142| EXPLANTED:| LEAD: MODEL 3778, LOT# V177008013| IMPLANTABLE:| LEAD: MODEL 3776, LOT# V006142| EXPLANTED: