BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2854648 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11066
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION OBTAINED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2012 AT WHICH TIME THEY WERE EVALUATED BY THEIR NURSE PRACTITIONER. THERE WERE NO CONCERNS WITH THEIR IMPLANTABLE NEUROSTIMULATOR (INS) NOTED AND THE PATIENT HAD NO OTHER ISSUES. THE HCP DECLINED TO GIVE FURTHER INFORMATION DUE TO PRIVACY CONCERNS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A URINARY TRACT INFECTION (UTI) PATIENT WAS ON ANTIBIOTICS AND THE HEALTH CARE PROVIDER WAS TRYING TO MAINTAIN THE INFECTION IN THE PATIENT'S KIDNEY AND BLADDER. IT WAS ALSO NOTED, THE PATIENT HAD KIDNEY STONES. PATIENT HAD HAD THE UTI FOR APPROXIMATELY TWO WEEKS. FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED, THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS UNKNOWN IF THERE WERE SIGNS AND SYMPTOMS ASSOCIATED WITH THE EVENT. IT WAS UNKNOWN IF THE PATIENT REQUIRED HOSPITALIZATION AND THE PATIENT OUTCOME WAS UNKNOWN. LATER THAT SAME DAY FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. IT WAS NOTED ABNORMAL IMPEDANCES WERE "N/A NONE." IT ALSO NOTED THE PATIENT HAD AN APPOINTMENT FOR EVALUATION SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention