BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3053368 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06030
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 14, 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
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A RECURRENCE OF THE PREVIOUSLY REPORTED EVENT. NO SPECIFIC PATIENT EFFECT OR SYMPTOM DETAIL WAS GIVEN REGARDING THE EVENT REOCCURRENCE. PER THE MANUFACTURING DEVICE REGISTRY, THE PATIENT DID UNDERGO A CATHETER REVISION ON (B)(6) 2013. THE PATIENT HAD PREVIOUSLY HAD A FLUID COLLECTION AT THE SPINE SITE WHICH REQUIRED A PRIOR SURGICAL INTERVENTION. (PLEASE SEE MANUFACTURING REPORT # 3004209178-2013-04283) THE MEDICATION BEING DELIVERED WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156424 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention