BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1864295 · Received October 7, 2010

    Report

    Report Number
    3004209178-2010-07728
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A PROBLEM WITH HIS STIMULATOR. THE PT'S IMPLANTABLE NEUROSTIMULATOR WAS EXPLANTED AFTER THE BATTERY DEPLETED. A COMPANY REP NOTED THAT THE "SETTINGS WERE HIGH." THE DEVICE WAS REPLACED AND THE PT RECOVERED WITHOUT SEQUELA. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL 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 IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT008486N| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT008487N