BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2153022 · Received June 28, 2011

    Report

    Report Number
    3004209178-2011-04848
    Event Type
    Death
    Date Received
    June 28, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 2, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED INCREASED PAIN. THE CATHETER HAD DISLODGED FROM THE INTRATHECAL SPACE. THE EVENT SEVERITY WAS REPORTED AS MODERATE. THE CATHETER WAS SURGICALLY REVISED ON (B)(6) 2011; THE CATHETER WAS SPLICED. IT WAS ALSO REPORTED THE PT'S PREEXISTING CONDITION HAD WORSENED OR EXACERBATED. THE DRUGS INFUSED VIA THE PUMP INCLUDED DILAUDID 2 MG/ML AND BUPIVACAINE 30 MG/ML. THE PT OUTCOME FOR BOTH EVENTS WAS REPORTED AS "DEATH".

    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 55 YR Female Required Intervention| D CATHETER - INTRATHECAL PORTION MODEL# 8709, LOT # N269412009.| EXPLANTED: | EXPLANTED: UNK| IMPLANTED: | IMPLANTED: | PROGRAMMER: MODEL 8835, LOT# NPG020686N.| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N284812011| PROGRAMMER: MODEL 8835, LOT# NPG020686N