BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2052525 · Received April 11, 2011

    Report

    Report Number
    3007566237-2011-02724
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE. THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT'S PUMP WAS ALARMING, AND DISPLAYED AN EVENT OCCURRED. THE HEALTH CARE PROVIDER (HCP) WAS UNABLE TO SILENCE THE ALARMS. THEY WOULD RESET THE PUMP TO A MINIMUM RATE TO SILENCE THE ALARM, BUT THE PUMP WOULD RESET. NEITHER A ROTOR NOR DYE STUDY WAS PERFORMED. THE PUMP WAS EXPLANTED AND REPLACED. THE EXPLANTED PUMP WAS STOPPED IN AN ATTEMPT TO SILENCE THE ALARM FOR SHIPMENT PURPOSES. A MFR ANALYSIS REPORT OF THE EXPLANTED PUMP WAS REQUESTED BY THE HCP. FOLLOWING THE PUMP REPLACEMENT PROCEDURE, THE PT HAD RECOVERED WITHOUT SEQUELA. THE MEDICATIONS BEING ADMINISTERED VIA THE PUMP WERE DILAUDID (30 MG/ML) AND BUPIVACAINE (40 MG/ML). ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8700V, LOT# J11633R09| EXPLANTED: