BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3951120 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13384
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS TO UNDERGO AN OPERATION. THE PATIENT WAS DOING WELL, BUT THEN STARTED HAVING SYMPTOMS, AS WELL AS SHOCKING. IT WAS DETERMINED VIA X-RAY THAT THE LEADS HAD MIGRATED INTO THE PELVIS. THE HEALTHCARE PROVIDER (HCP) WAS TO REPLACE THE LEADS AND DEAD BATTERY ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE BATTERY WAS REPLACED TODAY. IT WAS DISCOVERED THAT THE LEADS WERE STILL INTACT BUT IT WAS CONFIRMED THAT THE BATTERY WAS DEAD. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS IN CONTINUOUS MODE. IT WAS CONSIDERED NORMAL BATTERY DEPLETION BASED ON THE PATIENTS HIGH SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428362 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Required Intervention