BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 2931917 · Received January 28, 2013

    Report

    Report Number
    3007566237-2013-00301
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE ANCHOR REVEALED THE ANCHOR DID NOT PROPERLY DETACH FROM THE ASCENDA TOOL AND IT WAS NOT ABLE TO BE USED. THE PROXIMAL SIDE OF THE ANCHOR SHOWED SIGNIFICANT TEARING. THE ANOMALY WAS LIKELY RELATED TO THE SILICONE BOCKING THAT OCCURRED BETWEEN THE INTERACTION OF THE ANCHOR AND THE HYPOTUBE. RESULTS: NO LONGER APPLIES TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8781, LOT# 0206042813, PRODUCT TYPE: CATHETER. (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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE POSITIONING THE CATHETER DURING DEVICE IMPLANT, THE ANCHOR DID NOT COME OFF OF THE ANCHOR DISPENSER. AFTER THE ANCHOR DISPENSER WAS CONFIRMED, DAMAGE WAS OBSERVED. THE ANCHOR WAS NOT IMPLANTED. NO PATIENT SYMPTOMS OR INJURY WERE REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37916 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1