BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1870408 · Received October 11, 2010

    Report

    Report Number
    3004209178-2010-07822
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    May 26, 2010
    Report Date
    July 2, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER HAD A KINK. AS A RESULT, THE PUMP AND CATHETER WERE REPLACED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. FOR INFORMATION ABOUT EVENTS FOLLOWING THE REPLACEMENT, REFER TO MFR REPORT # 3004209178201007821. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IMPLANTABLE INFUSION PUMP: MODEL 8637-40| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N223478002| EXPLANTED:| IMPLANTED:| LOT# NGV435323H| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N152723014