BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 7207318 · Received January 19, 2018

    Report

    Report Number
    3007566237-2018-00211
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    January 28, 2002
    Report Date
    January 31, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCES THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE:: PRODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE CATHETER.

    Additional Manufacturer Narrative · 1

    REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT NO LONGER MEETS THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER ON (B)(6) 2018 REGARDING A PATIENT RECEIVING UNKNOWN MEDICATION (DOSE AND CONCENTRATION UNKNOWN) VIA AN IMPLANTED INFUSION PUMP. THE INDICATIONS FOR USE INCLUDED INTRACTABLE SPASTICITY AND MULTIPLE SCLEROSIS. IT WAS REPORTED THAT THE PATIENT'S CATHETER HAD BROKEN 6 TIMES SINCE THE PATIENT'S INITIAL IMPLANT IN (B)(6) 2002. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. [SEE MFG. REPORT #6000030-2008-00632; 6000030-2008-00633; 6000030-2008-00634; 3004209178-2015-01320; AND 3004209178-2016-17110 FOR OTHER 5 CATHETER BREAKS/TEARS].

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER ON (B)(6) 2018. IT WAS REPORTED THAT THERE WAS NO CATHETER BREAK ASSOCIATED WITH THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51308 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR