BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2982590 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03142
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 5, 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
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 435135 LOT# SERIAL# (B)(4), PRODUCT TYPE LEAD PRODUCT ID: 435135 LOT# SERIAL# (B)(4), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WANTED HER DEVICE REMOVED. IT WAS ALSO REPORTED, THE PATIENT FELT HER DEVICE WAS "NOT FUNCTIONING CORRECTLY." THE PATIENT ALSO REPORTEDLY STATED, THE DEVICE WORKED LESS THAN THREE YEARS, AND "DID NOT ACTUALLY HELP HER IN THAT PERIOD." IT WAS REPORTED, THE PATIENT'S DEVICE HAD NOT WORKED SINCE A YEAR PRIOR TO REPORT AND THE PATIENT DID NOT WANT A REPLACEMENT DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT HAVE BENEFIT FROM THE DEVICE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT WAS IMPLANTED ON (B)(6) 2009 TO TREAT THEIR GASTROPARESIS. IT WAS STATED THE PATIENT WAS SUFFERING PAIN AND COMPLICATIONS FROM THE DEVICE. IT WAS NOTED THE PATIENT HAD RADIATING PAIN IN THEIR ABDOMEN AND EXTREMITIES, NERVOUS SYSTEM DAMAGE, AND INCREASED PROBLEMS WITH THEIR DIGESTIVE SYSTEM. REPORTEDLY, THOSE PHYSICAL INJURIES HAD LED TO SEVERE ANXIETY AND DEPRESSION. IT WAS STATED THAT COMPONENTS OF THE DEVICE IMPLANTED HAD BROKEN, MALFUNCTIONED OR OTHERWISE FAILED. IT WAS REPORTED THE DEVICE WAS NOT PERFORMING ACCORDING TO THE SPECIFICATIONS OF THE MANUFACTURER NOR ACCORDING TO THE REPRESENTATIONS MADE TO THE PATIENT WHEN THEY AGREED TO RECEIVE THE IMPLANTED DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTS THE PATIENT HAD TO BE HOSPITALIZED TWICE AFTER SHE HAD IT IMPLANTED FROM HAVING SEVERE HIGH GLUCOSE NUMBERS, SEVERE HEART PAINS DUE TO THEIR STOMACH BEING BACKED UP AND NOT BEING ABLE TAKE A BM (BOWEL MOVEMENT) FOR OVER 15 DAYS. THE PATIENT HAD WANTED DEVICE EXPLANTED AFTER HER DEVICE HAD DEAD BATTERIES, WHICH SHE TOLD TO A REPRESENTATIVE FROM MANUFACTURER IN PERSON IN 2011. THE PATIENT WAS TYPE ONE BRITTLE DIABETIC AND HAVE HAD UNCONTROLLABLE SUGARS FOR 29 YEARS. AT THAT TIME, THE REPRESENTATIVE FROM MANUFACTURE TOLD HER THAT IT WAS CONFIRMED THAT THE BATTERIES OF HER DEVICE WERE IN FACT DEAD AND THAT SHE SHOULD GET THE BATTERIES REPLACED. THE PATIENT CLEARLY STATED THAT THE DEVICE SHE HAD IN HER NEVER WORKED, HAD CAUSED ME PAIN, AND STILL DOES TO THIS DAY; ELECTRICAL SHOCKING AND ALL SHE WANTED WAS IT TAKEN OUT. THE PATIENT HAD SEVERE PAIN TO HER LEFT SIDE AREA AND SIDE GOING TOWARDS THE BACK IN THE SAME AREA AS HER DEVICES. THE AREA WAS INFLAMED . ABOUT 1 AND 1/2 YEARS AGO THE PATIENT HAD AN ULTRASOUND DONE TO MAKE SURE IT WASN'T HER KIDNEYS. THE ULTRASOUND REPORT CAME BACK WITH IT NOT HAVING TO DO WITH HER KIDNEYS. THE DOCTOR WAS UNSURE OF THE FINDINGS AND TOLD HER SHE NEEDED THE DEVICE OUT. THE PATIENT DOCTORS TOLD HER TO REMOVE THE DEVICE ESPECIALLY SINCE THE BATTERIES HAD BEEN DEAD FOR THE LAST 3 YEARS. THE PATIENT REPORTS HER DEVICE HAD DAMAGED HER HEALTH, THE LEFT SIDE AND WHOLE AREA SURROUND THE DEVICE WAS IN CONSTANT PAIN AND TENDER ON A 24 HOUR BASIS. THE PATIENT WAS HURTING MORE AND MORE AS EACH DAY HAD PASSED AND WAS LOOKING IN TO A GENERAL SURGEON TO HAVE DEVICE REMOVED. THE PATIENT HAD BEEN SICK AND HAD LOST TRACK OF TIME TO REALIZE SHE WAS WAITING FOR HELP. THE PATIENT LIVES WITH PAIN IN STRESS AND ANXIETY ABOUT THE DEVICE SHE HAD IMPLANTED WHICH NEVER DID WHAT ITS INTENDED USE WAS. THE PATIENT WONDER WHY SHE NEVER GOT NOTICE OF THIS RECALL AND REPORTED THAT THE MANUFACTURER KNOWING BEFOREHAND THAT THEIR BATTERIES WERE IN FACT DEFECTIVE. SEE ATTACHED MW5039016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88428 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O