BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3071107 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06658
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT 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 THE PATIENT HAD A HUMMING NOISE IN HIS EARS THAT STARTED AFTER THE DEVICE IMPLANT AND CAN BE HEARD ALL THE TIME. THE PATIENT HAD REALLY STARTED TO NOTICE IT ON (B)(6) 2013. THE NOISE WAS MOSTLY IN THE PATIENT'S RIGHT EAR BUT THE PATIENT'S WHOLE HEAD WAS HUMMING AS WELL. IT WAS NOTED THE PATIENT DID NOT HAVE THIS ISSUE PRIOR TO IMPLANT AND BELIEVED IT WAS THE DEVICE MAKING NOISES. THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH THEIR HEALTH CARE PROVIDER (HCP) ON (B)(6) 2013. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THE PATIENT'S HCP HAD LOOKED AT THE PUMP ON (B)(6) 2013 TO CHECK THE HUMMING NOISE. IT WAS REPORTED THE HCP THOUGHT 'I MIGHT HAVE BEEN GETTING TOO MUCH MEDICINE AND THAT'S WHY I GOT THAT HUMMING NOISE IN MY EAR.' THE MEDICATION HAD BEEN DECREASED HOWEVER THE PATIENT STILL HEARD IT. 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
    172614 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR