BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 9497773 · Received December 19, 2019

    Report

    Report Number
    3007566237-2019-02582
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    August 28, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: ZOLL B, JEHANGIR A, EDWARDS MA, PETROV R, HUGHES W, MALIK Z, PARKMAN HP. SURGICAL TREATMENT FOR REFRACTORY GASTROPARESIS: STIMULATOR, PYLORIC SURGERY, OR BOTH? JOURNAL OF GASTROINTESTINAL SURGERY. 2019. DOI: 10.1007/S11605-019-04391-X. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE SEX OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S ACCEPTANCE DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID :3116, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3116, SERIAL/LOT #: UNKNOWN, UBD:(B)(4) , UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LITERATURE SUMMARY: THE ARTICLE SET OUT TO COMPARE THE CLINICAL OUTCOMES OF GASTRIC ELECTRIC STIMULATION (GES), PYLORIC SURGERY (PS) SUCH AS PYLOROMYOTOMY OR PYLOROPLASTY, AND SIMULTANEOUS GES+PS FOR REFRACTORY GASTROPARESIS (GP). THE AUTHORS FOUND THAT PATIENTS WITH REFRACTORY SYMPTOMS OF GP UNDERGOING GES, PS, OR COMBINED GES+PS EACH HAD SIGNIFICANT IMPROVEMENT OF THEIR GCSI TOTAL SCORE. GES AND COMBINED GES+PS SIGNIFICANTLY IMPROVED NAUSEA/VOMITING. THESE RESULTS SUGGEST GES OR COMBINED GES+PS APPEARS BETTER FOR NAUSEA/VOMITING PREDOMINANT REFRACTORY GP. REPORTED EVENTS: 1. 1 PATIENT HAD THEIR GASTRIC STIMULATOR REMOVED FOR INFECTION. 2. 1 PATIENT HAD THEIR GASTRIC STIMULATOR REMOVED FOR SEVERE PAIN. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292761 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention