BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4131401 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18034
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 9, 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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8782, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN HOSPITALIZED FOR THE PAST 14 MONTHS WITH SEIZURES AND RESPIRATORY ISSUES. IN (B)(6) 2014, THE CATHETER WAS REVISED BECAUSE IT HAD ¿SLIPPED OUT¿. ON THE DATE OF THIS REPORT, THE FAMILY WAS CONCERNED THAT THERE WAS SOMETHING GOING ON WITH THE CATHETER. THE PATIENT¿S CLONUS AND SPASMS HAD BEEN WORSE FOR A FEW DAYS AND THE PATIENT APPEARED MORE UNCOMFORTABLE. THE CATHETER WAS ASPIRATED; IT WAS DIFFICULT. THEY WERE ONLY ABLE TO WITHDRAW 1.5 ML AND IT WAS VERY SLUGGISH. THERE WERE NO CHANGES MADE TO THE PUMP RATE OR ANY OTHER INTERVENTIONS DONE. THE PATIENT¿S SYMPTOMS CONTINUED/WORSENED PER THE PATIENT¿S MOTHER. ON (B)(6) 2014, THE SIDE PORT WAS RECHECKED AND THERE WAS STILL SLUGGISH RETURN. THE PATIENT HAD NOT RECOVERED; THE SYMPTOMS/ISSUES WERE ONGOING. THE DEVICE SYSTEM WAS DELIVERING BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612001 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R