BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 15029506 · Received July 15, 2022

    Report

    Report Number
    3004209178-2022-09027
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    July 11, 2022
    Report Date
    July 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0592-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING MORPHINE VIA AN IMPLANTABLE PUMP. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND DID NOT FEEL WELL. THE CAUSE OF THE PATIENT'S SYMPTOMS WERE UNKNOWN, THE HCP THOUGHT THAT IT MIGHT BE COVID BUT DID NOT THINK IT WAS RELATED TO THE PATIENT'S MORPHINE DOSAGE. NONETHELESS, THE PUMP WAS INTERROGATED AND IT WAS FOUND THAT THE PUMP HAD STALLED ON (B)(6) 2022. THE PUMP REACHED TUBE SET ON (B)(6) 2022 AND DID NOT RECOVER UNTIL THE PUMP WAS READ ON (B)(6) 2022, 485 HOURS AND 10 MINUTES LATER. IT WAS REPORTED THAT THE PATIENT HAD AN MRI ON (B)(6) 2022. THE PATIENT REPORTEDLY HAD NOT HAD ANY WITHDRAWAL SYMPTOMS OR HEARD ANY ALARMS DURING THAT TIME. THE PATIENT HAD A BACK OPERATION, A L3-L4 STABILIZATION EXTENSION, ON (B)(6) 2022. THE OPERATION WAS REPORTEDLY RELATED TO THE PATIENT'S PAIN, BUT WAS NOT RELATED TO THE PATIENT'S PUMP. THE ISSUE WAS CONSIDERED RESOLVED AT THE TIME OF THE REPORT. NO SURGICAL INTERVENTION WAS PLANNED. THE PATIENT'S STATUS WAS LISTED AS "ALIVE - NO INJURY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047739 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Female