BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 4751876 · Received May 6, 2015

    Report

    Report Number
    3004209178-2015-08534
    Event Type
    Injury
    Date Received
    May 6, 2015
    Report Date
    April 10, 2015
    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
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD BEEN IN AND OUT OF THE HOSPITAL WITH MEDICAL ISSUES AND HAD A TERRIBLE FALL AND WINTER WITH THESE MEDICAL ISSUES. A HEALTHCARE PROVIDER WAS SUSPECTING THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY LIFE HAD BEEN GRADUALLY DIMINISHING. THE INS MAY NOT BE STIMULATING THE PATIENT¿S GASTROINTESTINAL (GI) TRACT THE WAY IT USED TO DUE TO BATTERY DEPLETION AND IT COULD BE CONTRIBUTING TO THE PATIENT¿S GI ISSUES. THE MANAGING HEALTHCARE PROVIDER INDICATED THAT THE INS WOULD MOST LIKELY NEED TO BE REPLACED THIS YEAR. THE PATIENT WAS SCHEDULED TO HAVE A KIDNEY AND PANCREAS TRANSPLANT AND NEEDED TO HAVE HER INS BATTERY LIFE CHECKED PRIOR TO SURGERY TO DETERMINE IF THE INS SHOULD BE REPLACED AT THE SAME TIME OF TRANSPLANT SURGERY. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297703 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization