BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 7412440 · Received April 10, 2018

    Report

    Report Number
    3004209178-2018-06919
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 23, 2018
    Report Date
    April 18, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169508149
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PROFESSIONAL (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING 10 MG/ML HYDROMORPHONE AT A DOSE OF 0.537 MG/DAY AND 0.6 MG/ML BUPIVACAINE AT A DOSE OF 0.03221 MG/DAY VIA AN IMPLANTABLE INFUSION PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT CAN IN FOR A REFILL AND AN EMPTY PUMP ALARM HAD OCCURRED ON (B)(6) 2018 THAT WAS CONFIRMED BY A CLINICIAN PROGRAMMER. THE PATIENT WAS HARD OF HEARING (HOH) AND DID NOT HEAR THE ALARM. THE PATIENT HAD MISSED THE REFILL. TROUBLESHOOTING RESOLVED THE REPORTED EVENT. NO SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS WERE EXPECTED OR ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP). IT WAS REPORTED THAT THE HCP WAS REFILLING THE PATIENT'S PUMP ON (B)(6) 2018 AND THE HCP PLANNED TO ASPIRATE THE CATHETER AS WELL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL. IT WAS REPORTED THAT THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT WAS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257586 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169508149

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR