BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4090548 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17058
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BREATHING PROBLEMS AFTER A DRUG DAILY DOSE INCREASE ON (B)(6) 2014. THE PATIENT WAS IN THE ICU (INTENSIVE CARE UNIT) ON THE DATE OF THIS REPORT HOWEVER THE DEVICE MANUFACTURER REPRESENTATIVE WASN¿T EXACTLY CLEAR ON THE TIMING OF THE PATIENT GOING TO THE ICU BUT SUSPECTED IT WAS (B)(6) 2014. THE PATIENT HAD ALSO BEEN WEARING A FENTANYL PATCH AND WAS USED LYRICA FOR SHINGLES AT THE TIME OF HER HOSPITALIZATION. THE REPRESENTATIVE WAS ALSO TOLD SHE HAD OTHER ORAL NARCOTICS AT HOME FOR AS NEEDED USE. UPON ARRIVAL TO THE ICU, THEY BEGAN A NARCAN DRIP TO MITIGATE THE SYMPTOMS OF THE NARCOTICS. THE REPRESENTATIVE WAS CALLED THERE AND THE DOSE WAS BROUGHT DOWN TO MINIMUM RATE THAT DAY. THE STATUS OF THE PATIENT NOW WAS UNKNOWN. THE PATIENT WAS STILL HOSPITALIZED AND UNDER CARE OF A HEALTH CARE PROVIDER (HCP). THE PATIENT¿S PTM (PERSONAL THERAPY MANAGER) PARAMETERS WERE ALSO PROGRAMMED FOR THE PATIENT. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE. THE OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION INCLUDING THE OUTCOME WAS REQUESTED HOWEVER IT WASN¿T AVAILABLE AS OF THE DATE OF THIS REPORT. IF FURTHER INFORMATION IS REPORTED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569642 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| L| R