BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3803052 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08821
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    November 14, 2013
    Report Date
    April 16, 2014
    Manufacturer
    MDT 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE THE PUMP WAS IMPLANTED THE PATIENT HAS HAD PROBLEMS WITH HIP PAIN, NO FEELING IN HIS FEET, AND LOST THE USE OF HIS LEFT LEG. THE PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) IN (B)(6) OF 2013 AND THE MRI REPORTEDLY ¿BURNED THE PUMP UP.¿ THE PUMP WAS NOT WORKING AT THE TIME OF THE MRI AS THERE WAS NO DRUG IN THE PUMP BECAUSE IT HAD RUN OUT. THE PUMP WENT EMPTY BECAUSE THE PATIENT DID NOT HAVE A PHYSICIAN TO FILL THE PUMP. THE PATIENT WANTED THE PUMP EXPLANTED AND A NEW PUMP IMPLANTED AS HE CONTINUED TO HAVE PAIN AND WAS LOOKING FOR A NEW PHYSICIAN. THIS DEVICE SYSTEM DELIVERED DILAUDID WHEN IT WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281581 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR