BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 3896818 · Received June 26, 2014

    Report

    Report Number
    3004209178-2014-12079
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PMA # WAS CORRECTED TO H990014. THE PREVIOUS PMA # WAS INCORRECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S NEWLY IMPLANTED NEUROSTIMULATOR SEEMED TO BE CAUSING THEIR INSULIN PUMP SENSORS TO ERROR OUT. IT WAS STATED THEY WERE WONDERING IF THEY SHOULD USE THE SENSORS BECAUSE THEY WERE FEELING A TINGLING SENSATION AT THE IMPLANT SITE. IT WAS NOTED THE PATIENT WOULD GET THE TINGLING SENSATION WHEN THEY USE THE INSULIN SENSORS AND THE ISSUE BEGAN WHEN THEY FIRST GOT HOME FOLLOWING THE IMPLANT. IT WAS REPORTED THE PATIENT HAD GONE THROUGH 5 SENSORS BECAUSE THEY KEPT GETTING ERRORS AND ONE SENSOR WOULD USUALLY LAST THEM 6 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374490 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR