BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3851768 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10203
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709, LOT# L71603, PRODUCT TYPE: CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A PUMP REPLACEMENT, THE HEALTHCARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE THE CATHETER, SO THE CATHETER WAS REPLACED. THE PATIENT HAD NOT HAD ANY SYMPTOMS OF WITHDRAWAL OR INEFFECTIVE THERAPY. THE MANAGING PHYSICIAN WAS ASKED ABOUT WHAT DOSE WOULD BE APPROPRIATE POST-OPERATIVELY. HE WANTED IT DECREASED BY 10%. THE ORIGINAL DOSE WAS 1300MCG/DAY. THE NEW DOSE WAS REDUCED TO 1170MCG/DAY. ON THE REPORT DATE AT APPROXIMATELY 9:30PM, THE IMPLANTING PHYSICIAN NOTIFIED A MANUFACTURER REPRESENTATIVE THAT THE PATIENT WAS HAVING SYMPTOMS OF OVERDOSE AND WAS BEING INTUBATED. AT APPROXIMATELY 10:30PM, THE DOSE WAS DECREASED BY 50%. THE FOLLOWING MORNING, THE DOSE WAS DECREASED AGAIN TO MINIMUM RATE. AT THE TIME OF THIS REPORT, THE PATIENT STATUS WAS ¿ALIVE-WITH INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT THE THERAPY WAS RESUMED AFTER DROPPING IT TO MINIMUM RATE. ON (B)(6) 2014 AT 17:00, THE RATE WAS RAISED TO 96.1MCG/DAY. THE FOLLOWING DAY AT 09:25, THE RATE WAS RAISED TO 114:9MCG/DAY. THE PATIENT WAS TO BE REASSESSED FOR FURTHER UPDATES OF THERAPY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A PUMP REFILL WAS NOT TO OCCUR FOR ¿A FEW MONTHS¿ FOLLOWING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329417 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Life Threatening| R