BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 4152902 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18508
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    May 21, 2014
    Report Date
    September 16, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE THE PATIENT GOT HAD MISSING PARTS. THE PATIENT¿S PROCEDURE HAD TO BE RESCHEDULED. THE PATIENT¿S DEVICE DID NOT SEEM TO BE DOING ITS JOB. THE PATIENT WAS IN CONSTANT PAIN AND GOT SHOCKED. SHE THOUGHT A LOT OF IT HAD TO DO WITH WHERE THE DEVICE WAS IMPLANTED AND IT WAS PLACED ON THE RIGHT SIDE INSTEAD OF THE LEFT SIDE BECAUSE OF HER INSULIN PUMP. THE PATIENT WAS MORE NAUSEOUS THAN EVER, HER WEIGHT WAS STILL DROPPING, AND SHE STILL WASN¿T ABLE TO EAT. BEFORE SURGERY THE PATIENT WAS ABLE TO EAT AND IT WOULD SIT THERE, NOW SHE WAS LUCKY IF SHE COULD GET WATER WITHOUT VOMITING. HER SYMPTOMS STARTED RIGHT AFTER IMPLANT. THE PATIENT HAD DISCUSSED THE ISSUE WITH HER HEALTHCARE PROVIDER. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630454 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR