BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2897161 · Received January 4, 2013

    Report

    Report Number
    3004209178-2013-00155
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    October 19, 2012
    Report Date
    August 1, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD AN INFLAMMATORY MASS. THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM INDICATES THAT THE CATHETER WAS REPLACED. THE DEVICE SYSTEM WAS DELIVERING DILAUDID, BUPIVACAINE, DROPERIDOL, AND BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED INTERMITTENT BILATERAL LOWER EXTREMITY (BLE) NUMBNESS; WORSE ON THE RIGHT LEG. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT ON (B)(6) 2012 AND HAD CTS OF HER BACK AND WAS DISCHARGED TO HOME. THE NUMBNESS OF THE BLE PERSISTED INTERMITTENTLY. ONE DAY PRIOR TO ADMISSION SHE STARTED HAVING SIGNIFICANT PARESTHESIA OF HER ABDOMINAL WALL. IT WAS PAINFUL TO TOUCH HER ANTERIOR ABDOMINAL WALL EVEN LIGHTLY. THE PUMP WAS IN THE RIGHT SUBCOSTAL AREA AND THERE WAS NO OBVIOUS INFECTION ON THIS SITE. THE PATIENT WAS NOTED TO HAVE ABNORMAL MRIS AND ADMISSION WAS ADVISED. THE BACK SPECIALIST STATED IT WAS MORE A NEUROLOGICAL PROBLEM. THE PATIENT WAS SEEN BY A NEUROLOGIST WHO STATED THAT THIS WAS NEURO PATHIC PAIN WITH SYRINX. THE PATIENT CONTINUED TO HAVE PAIN AND THERE WAS A QUESTION OF BILIARY DILATATION. GI WAS CONSULTED AND ORDERED A MAGNETIC RESONANCE CHOLANGIOPANCREATOGRAPHY (MRCP). HCP STATED THE ISSUE MIGHT BE THE PATIENT'S PUMP TIP THAT MAY BE CAUSING THE FLUID COLLECTION IN THE SPINAL AREA AND THE PATIENT NEEDS TO BE OPERATED ON THE FOLLOWING DAY. THE CATHETER WAS REPLACED ON (B)(6) 2012. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER VIA A CLINICAL STUDY REPORTED THE INFLAMMATORY MASS WAS AT THE CATHETER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5218 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R