BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 1971005 · Received January 6, 2011

    Report

    Report Number
    3004209178-2011-00129
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 30, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNS
    PMA / PMN Number
    H990014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT'S STIMULATION WAS TURNED ON, THEY EXPERIENCED A SHOCKING/JOLTING SENSATION. THE THERAPY STILL HELPED WITH SYMPTOMS. THE LOCATION OF THE DEVICE IS UNDER THE RIGHT BREAST WITH THE LEAD GOING DOWN AND ACROSS TO THE STOMACH. WHEN THE PT FELT SHOCKING IT WAS WHERE THE LEADS GO DOWN THE BODY, AND THE SHOCKING CAUSED THE MUSCLES TO CONTRACT AND BULGE. SOMETIMES THE SHOCKING WAS TRIGGERED BY THE PT USING THEIR ABDOMINAL MUSCLES TO GET UP. THE SYMPTOMS HAD WORSENED OVER THE LAST 4-6 WEEKS AND PRIOR TO THAT HAD OCCURRED INFREQUENTLY. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT005440N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT005439N