BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1892252 · Received November 2, 2010

    Report

    Report Number
    3004209178-2010-08741
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    December 1, 2009
    Report Date
    October 8, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD A PERIOD OF "ABRUPTLY INCREASED NAUSEA AND VOMITING" IN (B)(6) 2009. HIS STIMULATOR WAS INTERROGATED BY A PHYSICIAN, AND WAS FOUND TO BE NON-FUNCTIONING. THIS WAS VERIFIED BY A REPEAT INTERROGATION. IT WAS STATED HE HAD A SURGICAL EXPLORATION OF THE ABDOMINAL POCKET ON (B)(6), 2009 IN ORDER TO REMOVE WHAT WAS THOUGHT TO BE A MALFUNCTIONING STIMULATOR. THE STIMULATOR WAS THEN FOUND TO BE LYING 5CM FROM THE INITIAL POCKET SITE. BEFORE FURTHER EXPLORATION OF THE IMPLANT SITE WAS DONE, AN ADD'L INTERROGATION WAS PERFORMED AND THE STIMULATOR WAS FOUND TO BE FUNCTIONING AGAIN. ADJUSTMENTS WERE MADE IN THE STIMULATION PARAMETERS AFTER THE INCISION WAS CLOSED BY THE SURGEON. PT WAS DISCHARGED THAT DAY WITH IMPROVEMENT OF HIS NAUSEA AND VOMITING. TOTAL HOSPITAL STAY WAS LESS THAN 24 HOURS. HE HAS REPORTED NO FURTHER RECURRENCE OF THESE SYMPTOMS AND IT WAS REPORTED THE STIMULATOR REMAINED FUNCTIONAL IN FOLLOW-UP SEVERAL WEEKS LATER. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT 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 49 YR Required Intervention IMPLANTED:| LEAD: MODEL 4351, LOT# NHT003583N| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT002918N