BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2880055 · Received December 19, 2012

    Report

    Report Number
    3007566237-2012-03064
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    June 25, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER; PRODUCT ID 8731SC, LOT# B0986147K, PRODUCT TYPE CATHETER.

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER. THE ACTUAL EVENT DATE WAS NOT PROVIDED; THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH A PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    RUSSELL, L. J., LEROUX, A. A., WHEELOCK, W. B. TWISTED CATHETER CAUSING BACLOFEN PUMP MALFUNCTION: A CASE REPORT. CANADIAN JOURNAL OF NEUROLOGICAL SCIENCES. 2012;39:838-839. SUMMARY: A CASE REPORT PRESENTED ON A (B)(6) MALE DIAGNOSED WITH MULTIPLE SCLEROSIS. SIX (6) MONTHS AFTER PLACEMENT, THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS. AFTER INCREASING BACLOFEN DOSAGE, IT WAS FOUND THE ACTUAL RESERVOIR VOLUME (19 ML) WAS MUCH GREATER THAN THE EXPECTED (3 ML). THERE WAS ALSO DIFFICULTY ASPIRATING FROM THE CAP. A REVISION WAS PERFORMED ONLY TO FIND THAT THE PUMP SUTURES WERE DISCONNECTED, PUMP OVERTURNED, AND CATHETER WAS IN A LARGE KNOT. THE PATIENT RECEIVED A NEW CATHETER AND THE PUMP WAS REPOSITIONED IN THE ABDOMINAL POCKET. IN OUR CASE, WE BELIEVE THAT THE BREAKING OF THE SUTURES PREDISPOSED THE PUMP TO FLIP WITHIN AN OVERSIZED ABDOMINAL POCKET. THE PATIENT WAS COMPLETING SELF-TRANSFERS. WHICH MAY HAVE PROVIDED THE ADDITIONAL TORQUE NEEDED TO FLIP THE PUMP 23 TIMES. THE FLIPPING OF THE PUMP CAUSED THE CATHETER TO TWIST, LEADING TO THE OCCLUSION OF ITS LUMEN. OUR BELIEF IS THAT MULTIPLE CATHETER TWISTS WERE TRANSMITTED DOWNSTREAM. RESULTING IN A SECONDARY KNOT IN THE SPINAL CATHETER. THIS PREVENTED THE DELIVERY OF THE ITB TO THE CSF, CAUSING THE PATIENT TO EXPERIENCE SYMPTOMS OF ITB WITHDRAWAL. TWISTING OF THE CATHETER IS A RARE COMPLICATION OF ITB PUMP SYSTEMS. IT IS IMPORTANT THAT PHYSICIANS BE AWARE THAT IT IS A POTENTIAL COMPLICATION AND RECOGNIZE THE SIGNS OF PUMP MALFUNCTION. IT IS POSSIBLE TO DECREASE THE RISK OF PUMP ROTATION BY REDUCING THE SIZE OF THE INCISION AND ABDOMINAL POCKET VOLUME, AND ENSURING PROPER ANCHORING OF THE PUMP WITHIN THE POCKET. REPORTED EVENT: 6 MONTHS AFTER PLACEMENT, THE PATIENT EXPERIENCED A RETURN OF SPASMS. AFTER INCREASING BACLOFEN DOSAGE, IT WAS FOUND THE ACTUAL RESERVOIR VOLUME (19 ML) WAS MUCH GREATER THAN THE EXPECTED (3 ML). THERE WAS ALSO DIFFICULTY ASPIRATING FROM THE CAP. A REVISION WAS PERFORMED ONLY TO FIND THAT THE PUMP SUTURES WERE DISCONNECTED, PUMP OVERTURNED, AND CATHETER WAS IN A LARGE KNOT. THE PATIENT RECEIVED A NEW CATHETER AND THE PUMP WAS REPOSITIONED IN THE ABDOMINAL POCKET. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS STATED THAT THOUGH THE CATHETER WAS TWISTED, THERE WAS NO OTHER DEFECT PRESENT. THE PATIENT UNDERWENT A SECOND PUMP REPOSITIONING IN (B)(6) 2011 AFTER IT WAS NOT POSSIBLE TO ACCESS THE SIDE PORT AND X-RAY REVEALED THE PUMP WAS FLIPED ONCE AGAIN. THIS TIME A MESH POUCH WAS USED AND THERE WERE NO FURTHER PROBLEMS. THE PUMP WAS FUNCTIONING WELL AND THE PATIENT OUTCOME WAS AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention