BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4173816 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19731
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    August 29, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE EVENT INDICATES THE CORRECT AWARE DATE OF THIS EVENT IS (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION OF THEIR INTRATHECAL PAIN PUMP AND DEVELOPED PURULENT DRAINAGE OUT OF THE ABDOMINAL AND LUMBAR INCISIONS. IT WAS NOTED THAT SURGICAL REMOVAL AND WASHOUT WAS RECOMMENDED. NO OUTCOME OR DRUG INFORMATION WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. PLEASE REFER TO MANUFACTURER REPORT # 3004209178-2014-16590 FOR THE MOTOR STALL EVENT THAT LED TO THE REPORTED REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP WAS EXPLANTED DUE TO INFECTION.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A MANUFACTURER REPRESENTATIVE WAS AWARE OF THE POST-OP COMPLICATIONS THE DAY OF EXPLANT, (B)(6) 2014. THE PATIENT WAS ADMINISTERED PERIOPERATIVE ANTIBIOTICS AS A RESULT OF THE EVENT. THE PUMP AND CATHETER WERE EXPLANTED. IT WAS UNKNOWN WHAT SYMPTOMS THE PATIENT EXPERIENCED AS A RESULT OF THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654428 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention