BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2802787 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09467
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED PUMP MODEL/ SERIAL NUMBER TO 8637-40/ (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT WENT HOME AFTER SURGERY AND THE INCISION WAS NOT CLOSED PROPERLY. THE INCISION OPENED UP AND BECAME INFECTED. THE PATIENT WENT TO THE HOSPITAL AND THE PUMP WAS REPLACED. THE PATIENT STATED, ¿THE PUMP NOW WORKS GREAT FOR ME AND CHANGED THE QUALITY OF LIFE.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT PATIENT'S PUMP BEGAN TO ALARM. PATIENT WENT TO THE HOSPITAL AND "ONE HOUR AFTER PUMP BEGAN TO ALARM AND HIS POCKET SITE CAME OPEN". IT WAS ADDED THAT THE PATIENT HAD NOT EXPERIENCED ANY SYMPTOMS AT THE TIME OF THE PUMP ALARMING. PATIENT WAS ADMITTED FOR A FEW DAYS AND THE PUMP WAS EXPLANTED FROM THE RIGHT SIDE OF THE ABDOMEN AND A NEW PUMP WAS IMPLANTED ON THE LEFT SIDE OF THE ABDOMEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THAT THE PATIENT HAD THE PUMP REPLACED AND THEN THE INCISION HEALED. PER THE PATIENT, THE SYMPTOM WAS "LACK OF HEALING OF THE INCISION".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS THE PATIENT'S SECOND PUMP WHICH WAS INVOLVED WITH THE WOUND DEHISCENCE AND INFECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. ON THE DAY FOLLOWING IMPLANT, THE INCISION HAD COME OPEN AND THE PUMP CAME OUT OF THE PATIENT'S BODY. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R