BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2220248 · Received August 16, 2011

    Report

    Report Number
    3004209178-2011-06401
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 21, 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). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CHARGING OCCURRED MORE THAN EXPECTED. IMPEDANCE MEASUREMENTS WERE WITHIN THE NORMAL RANGE. ADDITIONALLY, THERE WAS A TEMPERATURE WARNING CAME ON AFTER 30 MINUTES OF CHARGING. SETTINGS WERE VERY LOW AND THE RECHARGER ANTENNA WAS REPLACED TWICE. THE PT EXPERIENCED BURNING PAIN AT THE POCKET SITE EVENT WHEN NOT CHARGING. HCP ATTEMPTED TO TREAT THIS BUT FINALLY DECIDED THAT THE PROBLEM COULD ONLY BE RESOLVED WITH REPLACING THE BATTERY. THE BATTERY WAS EXPLANTED (B)(6) 2011 AND WAS REPLACED WITH THE SAME DEVICE MODEL. POSTOPERATIVELY, THE PT WAS GETTING GOOD STIMULATION. THERE HAD NOT BEEN ANY FURTHER CHARGING ISSUES.

    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 41 YR Required Intervention LEAD: MODEL 3888, LOT# L42354| LOT# NJH703537H| EXTENSION: MODEL 37083, LOT# NKC002708N| PROGRAMMER: MODEL 7434, LOT# YN0011251P| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3890, LOT# J0309488V| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37711,| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD045991N| ACCESSORY: MODEL 37752, LOT# NKA029300N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC010761N| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD013259N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC002568N| EXPLANTED: