BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2544323 · Received April 23, 2012

    Report

    Report Number
    6000030-2012-00052
    Event Type
    Injury
    Date Received
    April 23, 2012
    Date of Event
    April 1, 2008
    Report Date
    February 1, 2019
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER, THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709, SERIAL/LOT# (B)(4), UBD: 2004-04-22, UDI# (B)(4). DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON (B)(6) 2008, IT WAS REPORTED THAT PATIENT HAD RETURN OF PATIENT SYMPTOMS. AS OF THE DATE OF THIS REPORT, IT WAS STATED THAT THERE WAS A KINKED CATHETER. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) INDICATED THE PATIENT'S WEIGHT WAS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 29-JAN-2019 FROM THE PATIENT WHO REPORTED THAT HER ¿CATHETER WENT BAD¿ AND WAS REPLACED IN 2008. PRIOR TO THE REPLACEMENT SHE HAD A BURNING SENSATION AND PAIN AT THE CATHETER SITE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention