BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 2980124 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-03103
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 435135 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    TWO LEADS WERE IMPLANTED AFTER THEIR USE-BEFORE DATES. ONE LEAD (SERIAL# (B)(4)) HAD A USE-BEFORE DATE OF (B)(6) 2012. THE OTHER LEAD (SERIAL# (B)(4)) HAD A USE-BEFORE DATE OF (B)(6) 2012. BOTH LEADS WERE IMPLANTED IN THE PATIENT ON (B)(6) 2013. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85377 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR