BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2962016 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02654
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    February 1, 2013
    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
    OH, 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEIGHT GAIN. THE PATIENT STATED THAT SHE TURNED HER IMPLANT UP TO 5V IN JULY AND RECEIVED THERAPEUTIC RELIEF, HOWEVER, PATIENT STATED SHE GAINED ABOUT 10 POUNDS SINCE THEN. THE PATIENT STATED SHE HAD GASTROPARESIS , SHORT GUT, AND OVERALL PAIN WHEN EATING. THE PATIENT STATED THAT SHE HAD HER PHYSICIAN TURN HER STIMULATION DOWN TO 1 VOLT. FOLLOW UP REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT THEY HAVE NOT SOUGHT FURTHER HELP. IT WAS LATER REPORTED BY THE HEALTH CARE PROVIDER THAT THE DEVICE WAS EXPLANTED. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS NOTED THAT WHEN THE DEVICE WAS TURNED UP TO 5 V THE PATIENT STILL HAD GAS PAINS AT THE SIDE OF HER STOMACH OR ¿SOME KIND OF PAIN.¿ THE PATIENT WAS, HOWEVER, NOT AS BLOATED AS BEFORE. THE PATIENT¿S DISSATISFACTION WITH THE WEIGHT GAIN PROMPTED THE AMPLITUDE ON THE DEVICE TO BE REDUCED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD HER IMPLANT REMOVED BECAUSE IT WAS BULKY AND ON TOP OF HER STOMACH, CAUSING PAIN. THE PATIENT STATED IT SHOCKED HER, ALTHOUGH IT DID HELP HER WITH NAUSEA.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT OUTCOME WAS LISTED AS NO INJURY. THE PATIENT WAS NOT HOSPITALIZED AT ALL FOR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64655 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention