BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2220222 · Received August 16, 2011

    Report

    Report Number
    3007566237-2011-06447
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 24, 2011
    Report Date
    January 13, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETE. INITIAL REPORTER UPDATED. THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO ANOMALY FOUND FOR THE PUMP.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PUMP WAS REPLACED. PER THE HCP PATIENT EXPERIENCED SYNCOPAL-LIKE EPISODES WHEN APPROACHING AND IN DAYS FOLLOWING PUMP REFILL (REPORTED PREVIOUSLY). A PROPHYLACTIC REMOVAL OF PUMP TO AVOID IN-VIVO BATTERY DEPLETION WAS INDICATED. IT WAS ADDED THAT THE PUMP WAS ALSO SENT TO HOSPITAL PATHOLOGY. PATIENT SUSTAINED NO INJURY AND RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    THE PT EXPERIENCED 3 SYNCOPAL EPISODES WITHIN THE LAST 4 WEEKS. ON (B)(6) 2011, THE FIRST SYNCOPE EVENT OCCURRED APPROX 1 HOUR FOLLOWING A REFILL PROCEDURE. DURING THE REFILL, THE HCP HAD ISSUES ACCESSING THE PUMP RESERVOIR; 5 ATTEMPTS WERE MADE TO ACCESS IT. IT WAS SUSPECTED THERE MAY HAVE BEEN A "PARTIAL" POCKET FILL. THE PT WENT TO THE EMERGENCY ROOM; THE PUMP WAS UPDATED 3 TIMES THAT DAY. THE SPECIFIC UPDATES WERE UNK PER THE REPORTER. ON (B)(6) 2011, THE PT EXPERIENCED A SECOND SYNCOPE EVENT APPROX 5 HOURS FOLLOWING A BRIDGE BOLUS COMPLETION. THE BRIDGE INVOLVED CHANGING THE CONCENTRATION OF THE SECONDARY DRUG CLONIDINE. APPROX 3-5 HOURS FOLLOWING THE 2ND SYNCOPAL EVENT; THE PT EXPERIENCED ANOTHER SYNCOPAL EVENT. ON (B)(6) 2011, THE PT WAS AT THE HCP CLINIC AND THE PUMP DAILY DOSE WAS DECREASED. TROUBLESHOOTING OF THE PUMP WAS BEING PERFORMED. THE PUMP EVENT LOGS WERE NORMAL. THE PT WAS ALSO TAKING ORAL PAIN MEDICATIONS. THE PT WAS BEING EVALUATED FOR THE CARDIAC ISSUES AND ALSO HAVING A NEUROLOGICAL WORK-UP PERFORMED. IT WAS LATER REPORTED THAT THE PT'S PUMP CONTAINED MORPHINE, CLONIDINE, AND COMPOUNDED BACLOFEN. THE PT WAS NOT DUE FOR ANOTHER REFILL UNTIL (B)(6) 2011. LAST SYNCOPAL EPISODE OCCURRED (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J12354R21