BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2760185 · Received September 26, 2012

    Report

    Report Number
    3007566237-2012-02315
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 4, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # J10834R34, IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CHANGE IN THERAPY EFFECT. THE PATIENT DIDN'T "SEEM LIKE HIMSELF." THE PATIENT'S LEGS WERE RIGID AND SHAKINESS WAS NOTED. THE SHAKINESS OCCURRED OFF AND ON WITHIN THE WEEK (OF THE DATE OF THE REPORT). THE PATIENT EXPERIENCED BLURRED VISION AND HIS EYES LOOKED LIKE HE WAS "HIGH." THE AREA AROUND THE PUMP WAS "SQUISHY"; THE INCISION WAS RED. IN ADDITION, THE PATIENT FELT WARM, HOWEVER, IT WAS UNKNOWN IF THERE WAS A FEVER. THE PATIENT WAS COMPLAINING OF HURTING IN HIS LEGS, EYES AND OTHER AREAS. THE REPORTER QUESTIONED IF THERE MAY BE A CATHETER ISSUE. THE NIGHT OF (B)(6) 2012 AND THE FOLLOWING NIGHT, THE ALTERNATE SYMPTOMS WERE NOTICED AND THE PATIENT WASN'T FEELING WELL. THE PUMP WAS LAST REFILLED ON (B)(6) 2012. ROUTINE X-RAYS TO THE PUMP WERE ALSO PERFORMED AT THAT TIME WITH NO ISSUES INDICATED. THERE WERE NO PUMP ALARMS NOTED. IT WAS LATER REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY DEPARTMENT IN WITHDRAWAL. THE PUMP SYSTEM WAS NOT FULLY EVALUATED AS THE PUMP WAS AT THE END OF LIFE DATE, AND A HIGHER LUMBAR LEVEL OF THE CATHETER PLACEMENT WAS DESIRED, THEREFORE A REPLACEMENT/REVISION OF THE PUMP SYSTEM WAS DESIRED REGARDLESS. THE PUMP AND CATHETER WERE BOTH REPLACED THEN ON (B)(6) 2012 AND THE PATIENT SUBSEQUENTLY "EXPERIENCED A TOTAL RESOLUTION OF SYMPTOMS." THE MEDICATION IN THE PUMP WAS LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THAT THE PATIENT¿S MOM STATED THE PATIENT ¿ALSO WAS HIGH OR DRUNK OR SOMETHING.¿ THE PATIENT¿S STOMACH HURT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R