BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1061425 · Received June 17, 2008

    Report

    Report Number
    3004209178-2008-03297
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    January 25, 2008
    Report Date
    May 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED A RELIABILITY NON-CONFORMANCE - PROPELLANT MISSING; SYNCHROMED II MANUFACTURING ISSUE. THE SERIAL NUMBER OF THE DEVICE IS INCLUDED IN THE SYNCHROMED II MISSING PROPELLANT RECALL AND PHYSICIAN COMMUNICATION DATED MAY 21, 2008.

    Description of Event or Problem · 1

    THE PATIENT'S PUMP WAS LAST REFILLED IN 2007 WITHOUT ANY DIFFICULTY. AT THE CURRENT REFILL, THEY TRIED TO FILL THE RESERVOIR WITH A MIXTURE OF DILAUDID, MARCAINE, AND BACLOFEN; IT WAS THE SAME MIXTURE THEY HAD USED OVER THE LAST FEW YEARS. THE PUMP WAS ACCESSED THE FIRST TIME AND THE APPROPRIATE AMOUNT OF SOLUTION, WHICH WAS SLIGHTLY OVER 3 MLS, WAS WITHDRAWN. THEN, THE FILTER WAS PLACED ON THE NEW SOLUTION AND THEY INJECTED APPROXIMATELY 20 MLS WHEN THE SYRINGE BECAME DIFFICULT TO INJECT. AT THAT POINT, THEY PUT THE REST OF THE SOLUTION IN A SMALLER SYRINGE TO SEE IF THAT WOULD BE EASIER TO INJECT, AND AGAIN, THEY ENCOUNTERED DIFFICULTY AT ABOUT 25 MLS. TO MAKE SURE THEY HAD NOT OVERFILLED THE PUMP IN THE PAST OR THE PUMP WOULD NOT FLOW WITH A ROTOR PROBLEM, THEY WITHDREW ALL THE SOLUTION FROM THE PUMP AND MEASURED IT TO BE 40 MLS COMPLETE; THERE WAS NO FURTHER FLUID IN THE PUMP. THEY WENT TO RE-INJECT THE DRUG MIXTURE AGAIN AND THEY WERE ONLY ABLE TO INJECT 25 MLS. THE HCP FELT THERE WAS EITHER AN ISSUE WITH THE DRUG VISCOSITY OR A BELLOWS PROBLEM WITH THE PUMP. THE DRUG MIXTURE WAS SENT FOR ANALYSIS, THE RESULTS WERE NOT REPORTED. THE HCP FELT THERE WAS LOW RISK TO THE PATIENT IN RECEIVING HER USUAL DOSE WITH THE PUMP FILLED SLIGHTLY LESS THAN USUAL, BUT PLANNED TO MONITOR HER CLOSELY. IN A MONTH EARLIER, THEY WERE AGAIN ABLE TO ASPIRATE FROM THE RESERVOIR, BUT COULD NOT INJECT MORE THAN 25 MLS OF DRUG INTO THE PUMP. THE PATIENT HAD 3 REFILLS SINCE IMPLANT AND THERE WERE NO ISSUES FOUND ASPIRATING OR REFILLING THE PUMP AT IMPLANT OR THE FIRST REFILL; HOWEVER, ON THE LAST TWO REFILLS, THE PUMP COULD ONLY BE FILED WITH 25 MLS OF DRUG. THE PUMP WAS REPLACED. THERE WERE NO PATIENT SYMPTOMS. THE PATIENT RECOVERED WITHOUT SEQUELA. AT EXPLANT, THE PUMP CONTAINED A MIXTURE OF DILAUDID, COMPOUNDED BACLOFEN AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709 LOT# J10846R01| PROGRAMMER MODEL 8840 LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER MODEL 8575 LOT# N067376