BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3781615 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08257
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    August 12, 2013
    Report Date
    April 9, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS OF THE PUMP FOUND NO ANOMALY. ANALYSIS OF THE CATHETER FOUND THE PIN CONNECTOR/COLLET WAS NOT FULLY LOCKED IN PLACE. LEAKING FROM UNDER THE STRAIN RELIEF WAS SEEN DURING PRESSURE TESTING NEAR THE CATHETER CONNECTOR AND WAS DETERMINED TO BE EXPLANTED DAMAGE (GOT PULL/STRESS DURING EXPLANT). DAMAGE WAS SEEN ON THE OUTER LAYER OF THE CATHETER BODY. A SLIGHT TEAR IN THE SEAL MATERIAL NEAR THE GUIDE RING WAS SEEN AS WELL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT¿S PUMP AND CATHETER WERE REMOVED ON (B)(6) 2014 DUE TO A POST SPINE FUSION WOUND INFECTION. THE PATIENT¿S DEVICES WERE RETURNED TO THE MANUFACTURER. PATIENT WAS BEING TREATED WITH LIOREDAL INTRATHECAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE SYSTEM DELIVERED GABLOFEN. PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE DATE OF ONSET/DIAGNOSIS OF INFECTION WAS 2014-(B)(6). IT WAS NOTED THE PATIENT DIDN¿T HAVE MENINGITIS. THE LAST REFILL DATE HAD BEEN 2014-(B)(6). SIGNS AND SYMPTOMS OF INFECTION INCLUDED REDNESS AND DRAINAGE. IT WAS SPECIFIED THE PRIMARY LOCATION OF THE INFECTION WAS THE LUMBAR REGION. A CULTURE IN THE REGION WAS OBTAINED; THE TYPE OF ORGANISM CULTURED WAS PSEUDOMONAS AERUGINOSA. IN TERMS OF INTERVENTIONS, IV (INTRAVENOUS) ANTIBIOTICS WERE INSTITUTED AS WELL AS THE DEVICE SYSTEM EXPLANT. IN TERMS OF PATIENT OUTCOME, IT WAS NOTED THE INFECTION RESOLVED AND THAT THE PATIENT EXPERIENCED DRUG WITHDRAWAL SYMPTOMS INCLUDING A RETURN OF SPASTICITY. IT WAS NOTED THE INFECTION WAS SECONDARY TO A SEPARATE OPERATIVE INFECTION, A ¿SPINAL FUSION INFECTION CONTAMINATED THE ITB CATHETER¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259888 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Required Intervention