BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TEMPORARY GASTRIC STIMULATOR

    MDR report key: 4192509 · Received October 22, 2014

    Report

    Report Number
    3007566237-2014-03068
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    June 19, 2001
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 30576SC, SERIAL# UNKNOWN, PRODUCT TYPE: SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FEVER WITH PROBABLY LINE (CENTRAL LINE) INFECTION. AN ESOPHAGOGASTRODUODENOSCOPY (EGD), ACUTE ABDOMINAL SERIES, PATHOLOGY REPORT STOMACH BIOPSIES, AND X-RAYS FOR TRIPLE LUMEN PLACEMENT. THE PATIENT WAS HOSPITALIZED FOR 7 NIGHTS AND RECOVERED WITH THERAPEUTIC ACTION ON (B)(6) 2001. HOWEVER, IT WAS ALSO STATED THAT THE EVENT CONTINUED WITH THERAPEUTIC ACTION. THE HEALTHCARE PROVIDER¿S IMPRESSION WAS ¿PROBABLE¿ MINIMAL LEFT BASILAR ATELECTASIS, LESS LIKELY EARLY PNEUMONIA AND EXTENSIVE POST-SURGICAL CHANGES WITH GASTROSTOMY TUBE IN PLACE. IT WAS NOTED THAT THE PATIENT HAD A FEVER OF 102 DEGREES ¿OR SO WITH SOME ANTERIOR CHEST WALL DISCOMFORT.¿ THE PATIENT REPORTEDLY HAD ¿SOME¿ NAUSEA, VOMITING, AND GASTROPARETIC SYMPTOMS, AS WELL AS TENDERNESS OVER LOWER THORACIC SPINE AND MULTIPLE BRUISES. LABORATORY DATA WAS UNREMARKABLE EXCEPT BLOOD CULTURES SHOWED GROWING GRAM (B)(6) COCCI IN CLUSTERS. AN EGD WAS PERFORMED AS THE PATIENT HAD A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACED FOR HER GASTROPARESIS AND DEVELOPED (B)(6). THE PATIENT REPORTEDLY STARTED ON EMPIRIC VANCOMYCIN. IT WAS SUSPECTED THAT THE PEG HAD BEEN INFECTED. THE FINAL DIAGNOSIS WAS BILE REFLUX, CHRONIC SUPERFICIAL GASTRITIS, AND PEG WAS IN GOOD CONDITION. IT WAS LATER REPORTED THAT THE PATIENT ¿JUST HAD¿ AN INFECTED PORT REMOVED FROM VEIN AND BOTH INNOMINATE VEINS WERE OCCLUDED. A LEFT INTERNAL TRIPLE-LUMEN CATHETER PLACEMENT WAS PERFORMED. PERMANENT DISABILITY WAS NOTED. FOLLOW UP WAS CONDUCTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672248 UNKNOWN TEMPORARY GASTRIC STIMULATOR INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S