BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1940669 · Received December 17, 2010

    Report

    Report Number
    3004209178-2010-10554
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE SPINAL SEGMENTS OF 3 CATHETERS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    DURING IMPLANT, THE PHYSICIAN HAD DIFFICULTY PLACING THE CATHETERS. INITIALLY DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS TO THE INTRATHECAL SPACE UTILIZING A VERY STEEP APPROACH ANGLE (APPROXIMATELY 85 DEGREES FROM THE SPINE) AND ATTEMPTED TO PLACE THE SPINAL SEGMENT OF (B)(4). THE CATHETER APPEARED TO LOOP ON THE FLUOROSCOPIC IMAGE AND STARTED TO TRAVEL IN THE CAUDAL DIRECTION. THE PHYSICIAN THEN REMOVED THE NEEDLE AND CATHETER AND ATTEMPTED A SLIGHTLY SHALLOWER ANGLE IN THE SAME INTERLAMINAR SPACE (L3-4) THIS TIME WITH (B)(4) WITH THE SAME RESULT. THIS CATHETER WAS REMOVED AND THE SAME WAS ATTEMPTED USING THE (B)(4) AND AGAIN THE SAME RESULT WAS SEEN. A NEW CATHETER WAS ATTEMPTED EACH TIME AS EACH HAD BECOME SOMEWHAT DEFORMED BY THE ATTEMPTS TO PLACE. FINALLY, THE NEEDLE WAS REMOVED AND REPLACED AT A SHALLOW PARAMEDIAN APPROACH IN THE L2-L3 SPACE. THIS TIME, THE SPINAL SEGMENT OF (B)(4) WAS PLACED WITHOUT COMPLICATION. THE 7.6 CM PUMP SEGMENT WAS DISCARDED. THE IMPLANTED PORTION OF THE (B)(4) (32.2 CM) WAS ATTACHED TO THE 66 CM PUMP SEGMENT OF (B)(4). THERE WAS REPORTED TO BE NO INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS GOING TO BE USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR CATHETER: MODEL 8709, LOT# N250773004| CATHETER: MODEL 8731SC, LOT# N274062005| CATHETER: MODEL 8731SC, LOT# N274062004| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: