BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3172896 · Received June 17, 2013

    Report

    Report Number
    3007566237-2013-01998
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER LATER REPORTED THAT THE EVENT WAS NOT RELATED TO THE INTRATHECAL PUMP. THE PATIENT VOMITED AND ASPIRATED SOME GASTRIC CONTENT WHILE UNDER IV SEDATION (MIDAZOLAM, FENTANYL, AND PROPOFOL) FOR A SPINAL INJECTION PROCEDURE. NO SURGICAL INTERVENTION OCCURRED. THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS FOR TREATMENT OF ASPIRATION PNEUMONITIS. THE PATIENT RECOVERED WITHOUT SEQUELAE. THE MEDICATIONS USED WITHIN THE SYSTEM WERE HYDROMORPHONE, BUPIVACAINE, DROPERIDOL, FENTANYL, AND CLONIDINE.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER REPORTED THAT ¿THE PATIENT WENT IN AND SHE ALMOST DIED BECAUSE SHE HAD ASPIRATED SOME OF HER STOMACH CONTENTS OR SOMETHING¿. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT LATER REPORTED THEIR HEALTHCARE PROVIDER GAVE THEM ¿SHOTS IN THEIR BACK¿ AND SHE WAS UNCONSCIOUS FOR THREE HOURS AT THE OFFICE; THAT THEIR HCP ¿ALMOST KILLED THEM¿. THE PATIENT STATED THIS OCCURRED ON (B)(6) 2013 AND THEY WERE SUBSEQUENTLY IN THE HOSPITAL FOR A WEEK. THEY ALSO STATED THEIR HCP ¿RIPPED UP THEIR THROAT REALLY BADLY¿ WITH A FEEDING TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273480 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening