BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3162604 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10146
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8781 LOT# SERIAL# (B)(4) IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8835 LOT# SERIAL# (B)(4) PRODUCT TYPE PROGRAMMER, PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S PUMP AND CATHETER WERE EXPLANTED DUE TO INFECTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 FOR EXPLORATORY SURGERY TO TAKE PLACE ON THE FOLLOWING DAY. AT THE SURGICAL INTERVENTION, THE HEALTHCARE PROVIDER (HCP) FOUND FLUID IN THE PUMP POCKET AND DETERMINED THE BEST COURSE OF ACTION WOULD BE TO REMOVE THE ENTIRE SYSTEM. THE INFECTION WAS NOTED AT THE DEVICE POCKET AND SYMPTOMS INCLUDED DRAINAGE AND INCISIONAL WOUND OPENING. IT WAS LATER REPORTED THE PATIENT WAS TO BE SEEN BY THE HCP ON (B)(6) 2013, AND THE HCP INDICATED THAT THE PATIENT WAS HEALING FINE, AND ONLY REQUIRING MEDICATION FOR PAIN. THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263354 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Hospitalization| R