BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2210524 · Received August 10, 2011

    Report

    Report Number
    3004209178-2011-06206
    Event Type
    Injury
    Date Received
    August 10, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A LOSS OF THERAPEUTIC EFFECT WAS REPORTED (NAUSEA). THE DEVICE "WORKED FOR 1 YEAR AND THEN THERE WERE PROBLEMS. THEN IT WORKED AGAIN." THE PATIENT NOTICED A RETURN OF SYMPTOMS IN (B)(6) 2011 AND SHE HAD BEEN HOSPITALIZED ON AND OFF SINCE (B)(6) 2011. ON (B)(6) 2011, THE PATIENT STATED A PHYSICIAN CHECKED THE NEUROSTIMULATOR AND INFORMED HER SHE "SHOULD HAVE 10 YEARS LEFT ON THE BATTERY." THE PHYSICIAN HAD NOT CONSULTED THE MANUFACTURER'S TECHNICAL SERVICES DEPARTMENT. THERE WAS NO KNOWN INCIDENT OR ACCIDENT RELATED TO THIS EVENT. ON (B)(6) 2011 THE PATIENT WAS IN THE HOSPITAL. IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS. DURING THE LAST REPROGRAMMING SESSION, IMPEDANCE WAS 579 OHMS. AN ENDOSCOPY WAS PERFORMED, BUT THE RESULTS WERE NOT PROVIDED. THE PATIENT HAD AN APPOINTMENT WITH HER PHYSICIAN SCHEDULED FOR (B)(6) 2011. 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 LNQ MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization LEAD: MODEL 4351, LOT# NHT003241N| LEAD: MODEL 4351, LOT# NHT003240N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: