BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 2050201 · Received April 1, 2011

    Report

    Report Number
    3004209178-2011-02512
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Report Date
    March 24, 2011
    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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POR (POWER ON RESET) ISSUE. POR HAD OCCURRED UPON INITIAL INTERROGATION. INS (IMPLANTABLE NEURO STIMULATION) SETTINGS WERE: STIM OFF, 0V, 330US, 14HZ, CYCLING ON 0.1, OFF 5.0. ADD'L INFO WAS REQUESTED.

    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 LEAD: MODEL 4351, LOT# NHT008363N| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT008661N| EXPLANTED:| EXPLANTED:| IMPLANTED: