BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1801153 · Received August 11, 2010

    Report

    Report Number
    3004209178-2010-06045
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 13, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTH CARE PROVIDER RESET PT'S "CANAP" SINCE IT HAD COME TO THE TOP OF THE PT'S SKIN, AND CAUSED PT A LOT OF PAIN. IT WAS DISCOVERED THE "CANAP" WAS BROKEN IN 3 PIECES AND PT HAD REVISION SURGERY (B)(6) 2010. ACCORDING TO THE DEVICE REGISTRATION SYSTEM, PUMP AND CATHETER WERE REPLACED. DRUG, DOSAGE AND CONCENTRATION WERE UNK. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE MADE AS A FOLLOW-UP AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709, LOT #J0058224R| IMPLANTED: