BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1132641 · Received August 22, 2008

    Report

    Report Number
    2182207-2008-05158
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - REFERS TO THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD UNDERGONE BACK SURGERY AND FOLLOWING SURGERY WAS TURNED " ROUGHLY" BY THE NURSE. TWO WEEKS AFTER THE SURGERY, AND AFTER LEAVING THE HOSP, THE PT WAS FEELING ILL WITH RETURN OF SYMPTOMS, CHEST PAINS, TROUBLE BREATHING, BLOATING, METALLIC TASTE IN HIS MOUTH, DRY MOUTH AND NAUSEA. THE PT "FELT LIKE HE WAS GETTING POISONED". THE PT'S PUMP CONTAINED FENTANYL 6000 MCG/ML AND BUPIVACAINE 7.5 MG/ML. THE PHYSICIAN DECREASED THE PT'S DOSE FROM 3200 MCG/DAY TO 1700 MCG/DAY AND THEN TO 1600 MCG/DAY. THE MEDICATION WAS TESTED AND EVERYTHING WAS FINE. AN X-RAY WAS PERFORMED, WHICH REVEALED THAT THE CATHETER WAS DISCONNECTED AT THE LUMBAR SITE. THE PT UNDERWENT A CATHETER REVISION. THE PT RECOVERED WITHOUT SEQUELA.

    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 49 YR Required Intervention EXPLANTED| EXPLANTED| CATHETER MODEL 8711 LOT # J12146R21| CATHETER MODEL 8598 LOT # N056294025| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED| IMPLANTED