BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4203532 · Received October 27, 2014

    Report

    Report Number
    3004209178-2014-20446
    Event Type
    Injury
    Date Received
    October 27, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS REVEALED THAT THE PUMP PASSED ALL NON-DESTRUCTIVE TESTING. NO ANOMALIES WERE NOTED IN THE PUMP LOGS. SINCE THE PUMP PASSED ALL NON-DESTRUCTIVE LAB TESTING, IT HAS BEEN DECIDED THAT NO DESTRUCTIVE TESTING NEEDS TO BE PERFORMED. THIS CHOICE PRESERVES THE PUMP FOR LATER RE-ANALYSIS IF NEEDED. THERE WAS NO CATHETER RETURN WITH THE PUMP.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, EXPLANTED: (B)(6) 2014, 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUSPECTED PUMP AND CATHETER ISSUE. WITH REGARD TO THE PUMP, IT WAS NOTED THAT THERE WAS AN ASPIRATION ISSUE, WHICH WAS SPECIFIED AS ¿VOLUME DISCREPANCY AND ABNORMAL REFLUX WHILE ASPIRING.¿ DIAGNOSTIC TESTING AND TROUBLESHOOTING CONSISTED OF X-RAYS (ALSO REPORTED AS A ¿SCANNER¿) AND AN MRI (MAGNETIC RESONANCE IMAGING). THE PRODUCT ISSUE WAS NOT RESOLVED, NOR WAS THE CAUSE OF THE ISSUE DETERMINED. PATENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT INCLUDED LESS THAN 50% THERAPY RELIEF. AS A RESULT OF THE EVENT, THE PUMP WAS EXPLANTED AND REPLACED. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE ¿ NO INJURY.¿ THE PUMP WAS BEING USED TO DELIVER MORPHINE. SUBSEQUENTLY, IT WAS CLARIFIED THAT ¿ABNORMAL REFLUX WHILE ASPIRATING¿ WAS ¿TOO MUCH LIQUID THAN EXPECTED¿; THERE WAS TOO MUCH DRUG IN THE RESERVOIR. PUMP LOGS WERE READ, BUT NO PUMP MALFUNCTION MESSAGES WERE SEEN DURING THE INTERROGATION. A ROTOR TEST WAS DONE AND WAS NORMAL, BUT THE HCP (HEALTHCARE PROVIDER) DECIDED TO EXPLANT THE PUMP ANYWAY. THE CATHETER ISSUE WAS NOTED TO HAVE BEEN AT THE DISTAL SEGMENT AND WAS SPECIFIED AS ¿TORSIONS IN THE PUMP SEGMENT OF THE CATHETER.¿ AS A RESULT OF THE CATHETER ISSUE, THE CATHETER WAS EXPLANTED. IT WAS REPORTED THAT, FOLLOWING PUMP REPLACEMENT, THE PATIENT WAS OK, BUT WAS NOT RECEIVING EFFECTIVE THERAPY. THE FIRST REFILL WAS SCHEDULED FOR (B)(6) 2014. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681620 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention