BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESYNCHROMED II

    MDR report key: 2182283 · Received July 11, 2011

    Report

    Report Number
    3007566237-2011-05281
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS REPLACED DUE TO END OF LIFE (EOL). IT WAS IMPLANTED OVER 6 YEARS AGO, IN 2005. THE PT HAD NO SYMPTOMS. PRIOR TO REPLACEMENT SURGERY, THE MANAGING PHYSICIAN TRIED TO ASPIRATE CATHETER THROUGH THE CAP, AND WHEN SHE COULDN'T, SET PT TO RADIOLOGY TO HAVE THEM TRY TO ASPIRATE CATHETER UNDER FLUOROSCOPY GUIDANCE, HOWEVER, THEY ALSO WERE NOT ABLE TO ASPIRATE. SURGEON ATTEMPTED TO ASPIRATE DURING REPLACEMENT SURGERY, BUT HE ALSO COULD NOT. BUT, HE DIDN'T REPLACED THE CATHETER BECAUSE "PT WAS NOT HAVING ANY WITHDRAWAL SYMPTOMS", AND CALCULATED THAT CATHETER MUST BE "OK", AND HELD PT IN HOSPITAL TO OBSERVE TO SEE IF ANY SIGNS OF WITHDRAWAL. POST-OPERATIVE, THE PT HAD NO COMPLAINTS. THE PT WAS DOING FINE AND WAS BEING MONITORED. A CATHETER REVISION AT A LATER DATE WAS A POSSIBILITY AS "DURING THIS REPLACEMENT, THE SURGEON COULD NOT AS HE DID NOT HAVE EQUIPMENT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention LOT# NGP355340H| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863720| CATHETER: MODEL 8709, LOT# J12260R35| EXPLANTED: