BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2964264 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02727
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 18, 2013
    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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER FOUND A CATHETER PUMP CONNECTOR ANOMALY. IT APPEARED THAT THE PUMP CONNECTORS STRAIN RELIEF SHROUD RIPPED AND SEPARATED FROM THE CONNECTOR IN VIVO. ANALYSIS OF THE PUMP FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A BREAK IN THE PUMP CONNECTOR. INTERVENTION WAS REQUIRED TO REPLACE THE CATHETER. IT WAS NOTED THAT T HERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. THE DRUG USED IN THIS SYSTEM WAS LIORESAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS A CATHETER KINK AND FRACTURE. THE ISSUE WAS LOCATED AT THE PROXIMAL PUMP SEGMENT. THE PATIENT HAD A MAGNETIC RESONANCE IMAGE (MRI), X-RAY, OR COMPUTED TOMOGRAPHY (CT) SCAN. A DOSE ADJUSTMENT WAS MADE AND A CATHETER DYE STUDY WAS PERFORMED. THE PUMP AND CATHETER WERE REPLACED. THE PATIENT WAS HOSPITALIZED. THE PATIENT OUTCOME WAS REPORTED AS SERIOUS INJURY/ILLNESS AND THE OUTCOME WAS ONGOING, BUT IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67802 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R