BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 5999644 · Received October 5, 2016

    Report

    Report Number
    3004209178-2016-20428
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    June 9, 2016
    Report Date
    November 16, 2016
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 4351-35, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 4351-35, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CONSUMER, HEALTH CARE PROVIDER (HCP), AND MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT HAD THEIR DEVICE IMPLANTED ON (B)(6) 2016. THE PATIENT WAS EXPERIENCING CONTRACTIONS THAT WERE VISIBLE ON THE OUTSIDE OF THE BODY SINCE IMPLANT. THIS HAPPENED THE DAY AFTER IMPLANT AND THERE WERE NO OTHER CIRCUMSTANCES THAT LED UP TO IT OTHER THAN IMPLANT. THE PATIENT COULD ALSO FEEL THEM AND IT MADE THEIR SIDES REALLY SORE. IT REMINDED THEM OF A PERSON THAT WAS PREGNANT WATCHING THEIR BABY KICK. THE PATIENT WANTED TO KNOW IF IT WAS JUST THEIR BODY TRYING TO ADJUST TO THE DEVICE AND CALLED THEIR HCP AND THEY SEEMED CONCERNED. THE HCP WOULD CONSULT THE SURGEON AND THE PATIENT SENT THEM VIDEO OF THE PATIENT'S STOMACH VISIBLY MOVING. THE CONTRACTIONS WERE STILL CONTINUING ON (B)(6) 2016. SOME DAYS WERE WORSE THAN OTHER DAYS. THE STEP TAKEN TO RESOLVE THE ISSUE WAS THAT THE PATIENT SAW THEIR HCP AND THEY TRIED TO ADJUST THE STIMULATOR, BUT IT HAD NOT HELPED. THE ISSUE HAD NOT BEEN RESOLVED AND THE PATIENT CONTINUED TO WORK WITH THEIR HCP. THE MANUFACTURER REPRESENTATIVE REPORTED THAT IF THERE WAS AN ISSUE THAT CAUSED MUSCLE CONTRACTIONS, THE DEVICE NEEDED TO BE TURNED OFF. THE CONSUMER AND HCP FURTHER REPORTED THAT THE ISSUE TENDED TO HAPPEN MORE AFTER THE PATIENT ATE AND IT JUST CONCERNED THEM IF IT WAS NORMAL. THE LAST ADJUSTMENTS THAT WERE MADE TO THE STIMULATOR SEEMED TO HAVE HELPED A LITTLE, BUT THE PATIENT WAS STILL NAUSEOUS. THE PATIENT KNEW THEY STILL HAD A LONG WAY TO GO, BUT HOPED IT WAS GOING TO WORK FOR THEM. THE PATIENT WAS GETTING SHOCKED BY THE GASTRIC PACEMAKER. IT WAS ONLY 1 SIDE OF THE ABDOMINAL MUSCLE THAT CONTRACTED, WHICH MADE THE HCP THINK IT COULD BE A WIRE ISSUE. THE PATIENT STILL HAD NOT HEARD ANYTHING FROM THE MANUFACTURER REPRESENTATIVE. THEY STILL HAD CONTRACTIONS, IT WAS UNCOMFORTABLE, AND CAUSED ISSUES SLEEPING. THE LAST TIME THE PATIENT SAW THEIR HCP WAS IN (B)(6) AND THEY TOLD THE PATIENT TO KEEP IN CONTACT AND LET THEM KNOW HOW IT WENT. THE HCP MADE 2 ADJUSTMENTS, BUT THE PATIENT STILL HAD THE CONTRACTIONS. IT WAS HELPING THE PATIENTNAUSEA. IT FELT LIKE A BABY WAS KICKING THEM AND THEY COULD FEEL IT ON BOTH SIDES OF THE ABDOMEN AND THEY COULD SEE IT AS WELL. THE HCP WAS SUPPOSED TO MEET WITH THE MANUFACTURER REPRESENTATIVE THIS WEEK AND WOULD BE IN CONTACT WITH THE PATIENT. THE HCP TOLD THE PATIENT THAT THE MANUFACTURER REPRESENTATIVE WOULD NEED TO BE PRESENT WHEN THEY REPLACED IT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE ISSUES THE PATIENT WAS HAVING WERE NOT DUE TO THE SURGEON, BUT DUE TO THE DEVICE. THE HEALTH CARE PROVIDER (HCP) HAD NEVER SEEN ANYTHING LIKE IT. THE ISSUE WAS DUE TO A SUDDEN CHANGE. THERE WERE NO TRAUMA OR FALLS RELATED TO THE ISSUE. THE PATIENT'S IMPEDANCE LEVELS WENT FROM 400-600 AND 64. THE PATIENT WAS TOLD THAT IMPEDANCES OF 800 WERE DANGEROUS AND THAT THE LEADS WOULD BE MOVING. CURRENTLY THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN TURNED OFF. THE PATIENT HAD STOMACH CONTRACTIONS AND COULD SEE THE STOMACH MOVE AND CONTRACT. THE DEVICE WAS DAMAGING THE PATIENT'S INSIDES AND THEIR STOMACH WAS SORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652452 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention