BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2200846 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06155
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    March 1, 2011
    Report Date
    July 13, 2011
    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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PT'S IMPLANTABLE NEUROSTIMULATOR TURNED OFF, ON ITS OWN, TWICE IN THE PAST FOUR MONTHS. THERE WAS NO KNOWN RELATED INCIDENT OR ACCIDENT REPORTED. THE PT DID NOT COME IN CONTACT WITH ANY STRONG ELECTROMAGNETIC INTERFERENCE (EMI). THE PT EXPERIENCED NAUSEA AND DEHYDRATION. DURING THE MOST RECENT OCCURRENCE, THE PT BECAME SO DEHYDRATED THAT CARDIAC ARREST, DUE TO LOW ELECTROLYTE LEVELS, OCCURRED. THE PT WAS TO MEET WITH THE PHYSICIAN ON (B)(6), 2011. AT THE MEETING, THE PT'S DEVICE WAS NOTED TO BE TURNED ON AND SET AT 6 VOLTS. ADD'L INFO WAS REQUESTED, BUT NOT AVAILABLE AS OF THE DATE 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 42 YR Required Intervention LEAD: MODEL 4351, LOT# NHT007377N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT007378N| EXPLANTED:| IMPLANTED: