BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3083281 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07030
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 16, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# J0056597R, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) DO NOT APPLY. 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO REPLACE THEIR PUMP. THE PATIENT'S WIFE STATED THAT THE PUMP WAS NOT FUNCTIONING RIGHT. THE PUMP'S ACTUAL RESIDUAL VOLUME (REPORTED AS 60 CC) EXCEEDED THE EXPECTED RESIDUAL VOLUME (REPORTED AS 10 CC). THE PATIENT'S WIFE LATER STATED THAT SHE DID NOT KNOW THE EXACT NUMBERS, BUT THERE WAS 'MUCH MORE LEFT EACH MONTH THAN SUPPOSED TO BE'. THE PATIENT'S WIFE REPORTED THAT THEY THOUGHT THE CATHETER WAS KINKED, HAD LEAKED, OR 'SCARRED DOWN AROUND IT'. THE MEDICATION USED WITHIN THE SYSTEM WAS PRIALT.

    Description of Event or Problem · 1

    THE EVENT DATE WAS NOTED TO BE 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185907 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention