BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4862475 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-12046
    Event Type
    Injury
    Date Received
    June 23, 2015
    Report Date
    June 1, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DEVICE RETURN, ANALYSIS FOUND A RESERVOIR ACCESS ISSUE DUE TO RESIDUE BEFORE AN INTERNAL DECONTAMINATION WAS PERFORMED. PREVIOUSLY REPORTED RESULT CODE NO LONGER APPLIES TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY APPLIED EVAL CONCLUSION CODE NO LONGER APPLIES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2015, PRODUCT TYPE CATHETER. F(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    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 THAT THE HEALTHCARE PROVIDER WAS UNABLE TO FILL AND UNABLE TO ASPIRATING THE RESERVOIR AT THE PATIENT¿S REFILL APPOINTMENT. THE PUMP WAS LAST REFILLED ON (B)(6) 2015. AT THE REFILL, THE EXPECTED RESIDUAL VOLUME (ERV) WAS GREATER THAN THE ACTUAL RESIDUAL VOLUME (ARV), ERV: 13.2 ML AND ARV: 0 ML. IT WAS UNKNOWN WHAT THE CAUSE OF THE VOLUME DISCREPANCY AND DIFFICULTY FILLING/ASPIRATING WAS. THE PATIENT HAD HOT FLASHES IN THE PAST WEEK. IT WAS NOTED THAT THE PATIENT WENT SCUBA DIVING WITHIN THE PAST WEEK, (B)(6) 2015, AND DOVE NO MORE THAN 30 FEET. THE HEALTHCARE PROVIDER ALREADY ATTEMPTED A LOCKED RESERVOIR VALVE PROCEDURE. THE DIFFICULTY FILLING THE PUMP DID NOT RESULT IN A POCKET FILL. THE PATIENT WAS NOT ABLE TO BE REFILLED. IT WAS REPORTED THAT THE PATIENT HAD THEIR PUMP REPLACED ON (B)(6) 2015. THE PHYSICIAN FELT LIKE THEY'VE TRIED ALL OF THE STEPS TO UNLOCK THE RESERVOIR VALVE AND NOTHING RESOLVED IT SO THE ONLY WAY TO CONTINUE GOOD THERAPY WAS TO REPLACE THE PUMP. AT THE TIME OF REPORT, THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. THE PUMP WAS USED TO INFUSE DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407515 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention