BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 3023966 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04305
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_WRENCH_ACC, PRODUCT TYPE - ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 3116 (LOT # NHV107579H) SHOWED INS SET SCREW BACKED OUT TOO FAR. FINAL ANALYSIS OF WRENCH ACCESSORY SHOWED HEX BENT; NO SIGNIFICANT ANOMALY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_WRENCH_ACC, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NEVER IMPLANTED INTO THE PATIENT. IT WAS NOTED THAT WHILE PREPARING THE INS, THE LOCKING SCREW FELL OUT AND WOULD NOT GO BACK IN. THE HCP THEN USED A NEW DEVICE. NO FURTHER INFORMATION WAS OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A "DEFECTIVE" IMPLANTABLE NEUROSTIMULATOR. IT WAS STATED THAT THE DEVICE WAS "FAULTY," BUT NO ADDITIONAL INFORMATION WAS GIVEN "REGARDING FAILURE." A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125867 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1