BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1844594 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07206
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 25, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE INS HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S INS WAS EXPLANTED, AND REPLACED WITH A NEW INS, DUE TO THE POSSIBLE PREMATURE DEPLETION OF THE DEVICE'S BATTERY. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADD'L INFO WAS REQUESTED, BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MDT PUERTO RICO OPERATIONS CO., JUNCOS 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention LEAD: MODEL 4351, LOT#: NHT008154N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT#: NHT008196N| EXPLANTED:| IMPLANTED: