BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2143052 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04686
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 27, 2011
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ACUTE OPIOD WITHDRAWAL AND WOUND INFECTION. THE CAUSE WAS IDENTIFIED AS POST-OPERATIVE COMPLICATION DUE TO CATHETER FRACTURE. THE CATHETER AT THE PROXIMAL SEGMENT OF THE PUMP HAD A BREAK. THE PT WAS HOSPITALIZED AND SUFFERED "SIGNIFICANT PAIN AND MORBIDITY". THE PUMP AND THE CATHETER WERE EXPLANTED. THE DRUGS INFUSED VIA THE PUMP WAS HYDROMORPHINE 8MG/DAY SINGLE CONTINUOUS, CONC 50MG/DL.

    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 45 YR Hospitalization| L| R CATHETER: MODEL 8709SC, LOT# N218541008| EXPLANTED:| IMPLANTED: