BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1080247 · Received July 22, 2008

    Report

    Report Number
    3004209178-2008-04221
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 6, 2007
    Report Date
    June 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.,
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2181-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER OF THE DEVICE IS INCLUDED IN THE SYNCHROMED II MISSING PROPELLANT RECALL AND PHYSICIAN COMMUNICATION DATED 2008.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE PUMP REVEALED -RESIDUE BUILD UP IN THE RESERVOIR BELLOWS. TESTING OF THE PUMP REVEALED NO MOISTURE DROPS WERE PRESENT ON THE BOTTOM SIDE OF THE INNER COVER OR IN THE MOTOR OR PUMP HEAD COMPARTMENTS. GEAR WHEEL 3 HAD SOME DISCOLORATION AND CORROSION. NO MOTOR STALL WAS SEEN DURING TESTING. DURING TESTING THE PUMP DISPENSED NORMALLY. DESTRUCTIVE ANALYSIS OF THE PUMP SHOWED NO ANOMALIES. THERE WAS A SINGLE STALL-AND-RECOVERY IN THE EVENT STATUS FIELD WHICH WAS MOST LIKELY DUE TO ELECTROMAGNETIC INTERFERENCE. REAL TIME X-RAYS SHOWED THERE WAS PROPELLANT IN THE PUMP. THE PUMP HEAD WAS CLEAN AND DRY AND PUMP TUBE SHOWED NO ANOMALIES. ALL ROLLER WHEELS TURNED FREELY. THERE WAS A SMALL AMOUNT OF DISCOLORATION / CORROSION ON THE PUMPHEAD PINS. ALL GEARS WERE CLEAN AND HAD NO SHAFT WEAR. THE PUMP CIRCUIT BOARD AND BATTERY COMPARTMENTS WERE CLEAN. THE PUMP WAS MILLED DOWN TO INSPECT ALL THE COMPONENTS IN THE FLUID PATH. SOME DRUG RESIDUE COULD BE SEEN IN THE BELLOWS CONVOLUTIONS. NO RESIDUE WAS SEEN IN THE OTHER COMPONENTS. ALL OTHER TESTING WAS NORMAL. FINAL DEVICE ANALYSIS RESULTS OF THE CATHETER REVEALED - NO ANOMALY FOUND. ACCEPTABLE CATHETER TESTING.

    Description of Event or Problem · 1

    AT IMPLANT, THE HEALTH CARE PROFESSIONAL (HCP) WAS ABLE TO REMOVE ALL THE WATER FROM THE PUMP. SINCE IMPLANT, THE PUMP'S RESIDUAL VOLUME WAS 15 MLS OR MORE AT REFILLS. THE HCP WAS ALSO HAVING DIFFICULTY REFILLING THE PUMP. NO PATIENT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT REPORTED THE PUMP WOULD NOT DELIVER MEDICATION AND WAS TURNED OFF BY THE PHYSICIAN 4 MONTHS AGO.

    Description of Event or Problem · 1

    THE HCP BELIEVED THE PUMP HAD NO PROPELLANT. THE PUMP WAS FULL AT EVERY REFILL, INCLUDING AT EXPLANT WHEN THE EXPECTED RESERVOIR VOLUME WAS 2 MLS AND THE ACTUAL VOLUME WAS 20 MLS. A DYE STUDY WAS PERFORMED (RESULTS NOT REPORTED). AT EXPLANT THE PROXIMAL CATHETER WAS REPLACED. THERE WAS CEREBROSPINAL FLUID FLOW FROM THE CATHETER. IT WAS REPORTED THERE WAS NO PATIENT INJURY. THE PUMP WAS USED TO DELIVER HYDROMORPHONE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female CATHETER: MODEL 8709, LOT # J10936R58, IMPLANTED| EXPLANTED| PROGRAMMER: MODEL 8840, LOT # UNK| EXPLANTED| CATHETER MODEL 8709| PROGRAMMER MODEL 8840