BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4210936 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20624
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 6, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER REVEALED A KINK ON THE CATHETER BODY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED A VOLUME DISCREPANCY OCCURRED AND THE EXPECTED RESIDUAL VOLUME (ERV) WAS 5 MILLILITERS (ML) AND THE ACTUAL RESIDUAL VOLUME (ARV) WAS 15ML. THE CAUSE OF THE DISCREPANCY WAS UNKNOWN. IT WAS NOTED A PUMP STUDY WAS TO BE SCHEDULED. IT WAS UNKNOWN IF THERE WERE ANY SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT AND THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ¿ALIVE-NO INJURY.¿ IT WAS FURTHER REPORTED THE PATIENT WAS SUPPOSED TO HAVE A PUMP STUDY ON (B)(6) 2014; HOWEVER SHE WENT TO THE WRONG FACILITY. THEY WERE IN THE PROCESS OF RESCHEDULING THE STUDY FOR NEXT WEEK AND A DYE AND ROLLER STUDY WERE BEING SCHEDULED. IT WAS UNKNOWN WHAT DRUG THE PUMP WAS BEING USED TO DELIVER, BUT THE PATIENT WAS NOT RECEIVING BACLOFEN AS THIS WAS A ¿PAIN PATIENT.¿ THE PATIENT¿S OUTCOME WAS UNKNOWN. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED A CATHETER ISSUE WAS SUSPECTED DUE TO BEING UNABLE TO ASPIRATE THE CATHETER. HOWEVER, NO SURGICAL ACTION HAD BEEN TAKEN BECAUSE THE PATIENT HAD BEEN RELUCTANT TO HAVE A CATHETER REVISION. THE CATHETER ISSUE WAS NOT DETERMINED AND NO FURTHER ACTIONS HAD BEEN TAKEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A CATHETER REVISION SURGERY WAS PERFORMED. THEY WERE UNABLE TO DETERMINE WHY NO CEREBROSPINAL FLUID (CSF) COULD BE ASPIRATED FROM THE CATHETER. A NEW CATHETER WAS PLACED WITH GREAT CSF FLOW. A PRE-OPERATIVE DIAGNOSIS OF ¿PUMP FAILURE¿ WAS NOTED, BUT IT WAS ALSO NOTED THAT A ROTOR STUDY WAS NORMAL.

    Description of Event or Problem · 1

    INITIALLY A PUMP ISSUE WAS SUSPECTED, HOWEVER, THE PUMP SEEMED TO BE WORKING FINE. THE PHYSICIAN SUSPECTED A CATHETER OCCLUSION AS ONCE THE NEW CATHETER WAS ATTACHED THEY WERE ABLE TO GET COULD FLOW.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE DELIVERED MORPHINE. THE CAUSE OF THE DISCREPANCY WASN¿T ABLE TO BE DETERMINED. THE PUMP STUDY WAS RE-SCHEDULED HOWEVER THE DEVICE MANUFACTURER REPRESENTATIVE DIDN¿T KNOW THE DATE BUT DID KNOW THAT THE CATHETER WAS UNABLE TO BE ASPIRATED. THE PATIENT WAS CURRENTLY WAITING FOR A CATHETER REVISION SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED INCLUDING WHAT ACTIONS OCCURRED TO RESOLVE THE EVENT AND THE PATIENT¿S OUTCOME BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694122 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention