BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 8640443 · Received May 24, 2019

    Report

    Report Number
    3004209178-2019-10232
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 24, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169530126
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INDICATED A PMA/510K NUMBER OF P860006 IN ERROR AND HAS BEEN CORRECTED IN THIS REPORT TO INDICATE P960004. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (NURSE PRACTITIONER) REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN WITH CONCENTRATION 1000 MCG/ML AT A DOSE RATE OF 316.4 MCG/DAY VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS DUE FOR A REFILL. THE PATIENT HAD MISSED AN APPOINTMENT AND ON (B)(6) 2019 THERE WAS A CRITICAL ALARM FOR EMPTY PUMP. WHEN THEY CHECKED THE PUMP ON (B)(6) 2019 THERE WAS 1.5 ML IN THE PUMP. THE POSSIBILITIES OF HAVING WITHDRAWN A SMALL AMOUNT FROM THE DEAD SPACE IN THE PUMP RESERVOIR OR THAT OTHER FACTORS COULD HAVE LED TO THE PUMP NOT BEING COMPLETELY EMPTY SUCH AS A PARTIAL CATHETER OCCLUSION OR KINK WERE BEING CONSIDERED. THE PATIENT WAS DESCRIBED AS HAVING SEEMED MORE SPASTIC BUT THAT HE WAS AN ALCOHOLIC, SO THE HCP DIDN¿T THINK THE PATIENT WOULD KNOW. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434123 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169530126

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR