BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2850039 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10897
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8835 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT: PRODUCT ID, 8784 SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER: PRODUCT ID, 8781 SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE WHEN THE HCP ATTEMPTED TO ATTACH THE CATHETER TO THE COLLET, THE HEAD OF THE COLLET BROKE FREE. THE HCP PUSHED THE COLLET HEAD BACK INTO PLACE. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. PATIENT STATUS WAS NOTED AS "ALIVE - NO INJURY/NO ADVERSE EVENT". THE PUMP WAS DELIVERING DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR