BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED UNKNOWN

    MDR report key: 1864327 · Received October 7, 2010

    Report

    Report Number
    3007566237-2010-07710
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    August 1, 2010
    Report Date
    October 4, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WITHDRAWAL. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PT. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PTS. AT THIS TIME, NO ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: DVORAK EM, MCGUIRE JR, NELSON ME. INCIDENCE AND IDENTIFICATION OF INTRATHECAL BACLOFEN CATHETER MALFUNCTION. PM R AUG 2010; 2(8):751-756. SUMMARY: A RETROSPECTIVE CHART REVIEW OF 167 ADULT PTS WITH INTRACTABLE SPASTICITY AND ITB PUMP IMPLANTED BETWEEN (B)(6) 1994 AND (B)(6) 2009. THE AIM WAS TO REVIEW THE FREQUENCY OF ITB COMPLICATIONS IN PTS FROM THE STUDY AUTHORS' SPASTICITY CLINIC OVER 15 YEARS AND THE TESTS USED TO IDENTIFY THESE PROBLEMS. THIRTY-THREE PTS AND 37 CATHETER REVISIONS (FOUR PTS HAD 2 COMPLICATIONS, THE REST EACH HAD ONE). RADIOGRAPHS WERE OBTAINED IN ALL CASES TO DETERMINE CATHETER ISSUE. REPORTABLE EVENTS: THERE WERE: 14 CATHETER KINKS AND/OR OBSTRUCTION; 7 CATHETER DISCONNECTIONS FROM THE SIDE PORT; 7 SUBDURAL CATHETER PLACEMENTS; 4 CATHETER FRACTURES; 4 CATHETER DISLODGEMENTS FROM THE SPINAL CANAL AND ONE PUMP FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| CATHETER: MODEL CATHETER, LOT# UNK| EXPLANTED: