BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4172247 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19694
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    PER THE HCP (HEALTHCARE PROFESSIONAL), THE PATIENT DID NOT HAVE AN INFECTION. THE PATIENT WAS ON ORAL ANTIBIOTICS. THE HCP NOTED "PROBABLY STERILE ABSCESS; NO SYMPTOMS OF INFECTION."

    Description of Event or Problem · 1

    THE PUMP WAS ONE MONTH TO ERI (ELECTIVE REPLACEMENT INDICATOR) AND WAS REPLACED ON (B)(6) 2014. DURING THE REPLACEMENT THEY DISCOVERED A ¿NICK¿ ON THE CATHETER NEAR THE PUMP CONNECTION. THE CATHETER CONNECTOR WAS REPLACED WITH AN (B)(4). THE PUMP WAS USED TO DELIVER DILAUDID. NO PATIENT SYMPTOMS OR OUTCOME REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN INFORMATION. IF FURTHER INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT PRE AND POST OP. THE PATIENT DID NOT HAVE ANY SYMPTOM PRIOR TO THE REPLACEMENT THAT WOULD INDICATE AN ISSUE WITH THE CATHETER. THE COMPANY REPRESENTATIVE BELIEVED THAT PATIENT IS DOING FINE AT THIS TIME, AS THEY HAVE NOT HEARD FROM THE PHYSICIAN SINCE THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654925 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention