BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4233757 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21114
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 15, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8578, LOT# N166722018, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2014 WITH THE FOLLOWING SYMPTOMS: HIGH BLOOD PRESSURE, LOW GRADE FEVER, TACHYCARDIA, INCREASED SPASTICITY AND TONE. THE PATIENT¿S HEART RATE WAS IN THE 140-150 RANGE, THE PATIENT¿S BLOOD PRESSURE WAS 170, AND THE PATIENT¿S LACTIC ACID LEVEL WAS 3.4, WHICH WAS CONSIDERED HIGH. THE MANUFACTURING REPRESENTATIVE REPORTED THERE WERE NO PUMP ALARMS. THE PUMP AND CATHETER APPEARED TO BE FINE, AND THE CATHETER WAS PATENT AT THE TIME OF PUMP REPLACEMENT ON (B)(6) 2014. THE PREVIOUS PUMP REACHED EXPECTED LONGEVITY, AND WAS REPLACED. THE REPLACEMENT WAS PRIOR TO THE START OF THE PATIENT¿S SYMPTOMS. THE PATIENT WAS GOING TO BE CHECKED FOR PNEUMONIA AND OTHER POSSIBLE ILLNESSES. IT WAS REPORTED THE PATIENT¿S CONDITION COULD BE UNRELATED TO THE PUMP. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED AT THAT TIME. FURTHER INFORMATION WAS REPORTED THAT THE PATIENT DEVELOPED FLUID IN THE PUMP POCKET, AND WAS SYMPTOMATIC. A X-RAY WAS PROVIDED, AND NO ANOMALIES WERE IDENTIFIED. THE DECISION WAS MADE TO PERFORM POCKET EXPLORATION ON (B)(6) 2014. IT WAS DETERMINED THE SUTURELESS CONNECTOR (SC) WAS NOT ON TIGHT, AND SEEMED TO BE A BIT ANGLED. A CATHETER REVISION TOOK PLACE ON (B)(6) 2014. THE HEALTHCARE PROVIDER (HCP) COMPLETELY DISCONNECTED THE CATHETER, RECONNECTED IT, AND THEN PERFORMED A (B)(6) STUDY WHEN THE CATHETER WAS ATTACHED TO THE PUMP AND WHEN THE CATHETER WAS DISCONNECTED FROM THE PUMP. THE CATHETER WAS CONFIRMED TO BE INTACT WITH NO FURTHER ISSUE. THE PUMP WAS USED TO DELIVER LIORESAL. THE PATIENT¿S DOSE WAS DECREASED FROM 1500 MCG/DAY TO 1000 MCG/DAY BECAUSE THE HCP WAS GOING TO KEEP THE PATIENT ON 20 MG OF ORAL BACLOFEN FOR THE TIME BEING. IT WAS THEN REPORTED THE PATIENT¿S PUMP DOSE WAS INCREASED TO SLOWLY WEAN THE PATIENT OFF OF ORAL MEDICATION. THE PATIENT WAS TO BE DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. THE PATIENT WAS RECEIVING ADEQUATE THERAPY, AND WAS DOING WELL. FURTHER FOLLOW-UP WAS CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715131 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Hospitalization| R