BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1222428 · Received November 5, 2008

    Report

    Report Number
    2182207-2008-07218
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 9, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND - NORMAL DEVICE FUNCTION. FINAL DEVICE ANALYSIS OF THE CATHETER REVEALED A PROCEDURAL NON-CONFORMANCE - HOLE IN CATHETER - USER RELATED. THE PROXIMAL PIECE OF THE CATHETER HAD A SMALL HOLE LOCATED 22.1 CM FROM THE PROXIMAL END. CATHETER.

    Description of Event or Problem · 1

    THE PATIENT WAS RECEIVING LIORESAL 2000 MCG/ML VIA THE PUMP. THE PATIENT REQUESTED THAT THE PUMP BE EXPLANTED DUE TO PSYCHIATRIC COMPLICATIONS, WHICH INCLUDED EPISODES OF AGITATION AND DEPRESSION. THE PATIENT EXPERIENCED PSYCHOLOGICAL SIDE EFFECTS FOLLOWING WHAT THE FAMILY SAID WAS A BOLUS. THE PATIENT WAS HOSPITALIZED FOR 2 WEEKS. IN 2008, THE PUMP WAS FILLED WITH NORMAL SALINE IN PREPARATION FOR THE SYSTEM EXPLANT. THE SYSTEM WAS EXPLANTED.

    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 Hospitalization| R PROGRAMMER MODEL 8840 LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| MODEL 8709 LOT# J12509R12