BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 1872611 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07875
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE LEAD WAS PLACED DURING SURGERY, THE IMPEDANCE WAS "VERY HIGH." THE PT COULD NOT BE PROGRAMMED, AND THE LEAD WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37714 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention LEAD: MODEL 3776, LOT# V437670003| EXPLANTED:| LEAD: MODEL 3776, LOT# V440601028| PROGRAMMER: MODEL 37744, LOT# NKT001030N| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3776, LOT# V440601028