BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1872800 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07953
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 16, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECHARGER WAS NOT CHARGING THE DEVICE. PATIENT INDICATED THAT IT TOOK SEVERAL HOURS TO RECHARGE WITH THE RECHARGER. THE PATIENT WAS CHARGING MORE THAN EXPECTED AND THE PATIENT THOUGHT IT TOOK LONGER TO CHARGE THAN USUAL. THE PATIENT UNDERWENT LEAD REVISION A FEW WEEKS AGO AND ACCORDING TO THE REPRESENTATIVE, ENERGY NEEDS HAVE INCREASED. IT WAS RECOMMENDED TO RECHARGE THE DEVICE USING A DIFFERENT RECHARGER TO SEE IF CHARGING EXPERIENCE CHANGES. BASED ON ESTIMATED PARAMETERS, THE BATTERY LONGEVITY IS APPROX 4.9 DAYS AND 2.1 TOWARD END OF LIFE (EOL). PATIENT HAS VERY HIGH SETTINGS. PATIENT STATED HE HAD NEVER BEEN ABLE TO CHARGE TO 100% - AND IT NEVER GOES BY 50%. THE PATIENT STATED HE DID NOT HAVE STIMULATION ON DURING THE RECHARGE. HE HAD GOOD COUPLING AND DID KEEP A WATCH FOR CONSTANT COMMUNICATION. THE RECHARGER WAS RETURNED FOR A NEW RECHARGE ANTENNA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention LEAD: MODEL 3778, LOT# V288379021| ACCESSORY: MODEL 37791, LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE138427N| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA128983N| LEAD: MODEL 3778, LOT# V524633028| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V524633026