BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 7992006 · Received October 22, 2018

    Report

    Report Number
    3004209178-2018-23615
    Event Type
    Injury
    Date Received
    October 22, 2018
    Date of Event
    November 1, 2017
    Report Date
    November 21, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    UDI-DI
    00643169174993
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 435135, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 435135, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 435135, SERIAL/LOT #: UNKNOWN, (B)(4) PERTAIN TO PRODUCT ID: 435135, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    NO NEW INFORMATION WAS REPORTED (THE PATIENT'S WEIGHT WAS REPORTED).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE PATIENT HAD TYPE I DIABETES COMPLICATED BY SEVERE GASTROPARESIS AND GERD WITH BE. THE PATIENT HAD HAD A FUNDOPLICATION, PYLOROPLASTY, AND A GASTRIC NEUROSTIMULATOR (GNS) IMPLANTATION IN THE PAST, AND HAD DEVELOPED A PARAESOPHAGEAL HERNIA WITH RECURRENT GERD AND HAD FRACTURED ONE OF THEIR GNS LEADS; IT WAS NOTED THAT THIS WAS ALL FOLLOWING A MOTOR VEHICLE CRASH/COLLISION (MVC). THE PATIENT¿S PREOPERATIVE DIAGNOSIS INCLUDED SYMPTOMATIC PARAESOPHAGEAL HIATAL HERNIA WITH RECURRENT GERD AND DIABETIC GASTROPARESIS. PROCEDURES PERFORMED INCLUDED: LAPAROSCOPIC REVISION PARAESOPHAGEAL HIATAL HERNIA REPAIR WITH IMPLANTATION OF MESH REINFORCEMENT OF THE DIAPHRAGMATIC CLOSURE; LAPAROSCOPIC REVISION FUNDOPLICATION; UPPER ENDOSCOPY; LAPAROSCOPIC GNS LEAD REMOVAL; LAPAROSCOPIC GNS LEAD IMPLANTATION; AND GNS PROGRAMMING. IT WAS NOTED THAT DURING THE PARAESOPHAGEAL HIATAL HERNIA REPAIR, A 1 CM ANTERIOR ENTEROTOMY OCCURRED AND WAS CLOSED. THE BROKEN LEAD WAS REMOVED AND REPLACED AND THE FINAL GNS SETTINGS WERE: IMPEDANCE 388, CURRENT 5MA, AND VOLTAGE 1.9V. IT WAS NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL, THERE WERE NO APPARENT COMPLICATIONS, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833295 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116 00643169174993

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention