BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2873819 · Received December 14, 2012

    Report

    Report Number
    3007566237-2012-03016
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE CATHETER REVEALED AN AREA OF THE CATHETER BODY WAS COMPRESSED DUE TO THE PATIENT'S ANATOMY AND POSSIBLY CAUSED AN OCCLUSION. AN AREA OF ABRASION WAS SEEN 3.5 CM FROM ITS PROXIMAL END, AND IT WAS SUSPECTED THAT THE ABRASION WAS CAUSED BY THE ANATOMY OF THE PATIENT'S SPINE. ANALYSIS RESULTS FOR THE PUMP WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN PUMP ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012; CATHETER: MODEL 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT SUBMITTED TO INCLUDE ADDITIONAL CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), PRODUCT TYPE CATHETER; PRODUCT ID 8596, SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AN ANALYSIS WAS DONE ON THE PUMP AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT AFTER THE CATHETER REVISION SURGERY ON (B)(6) 2012, THE PATIENT EXPERIENCED CEREBROSPINAL FLUID (CSF) LEAKING AT THE CATHETER SPINAL INSERTION SITE. AFTER A BLOOD PATCH WAS PERFORMED ON (B)(6) 2012 THE PATIENT EXPERIENCED SWELLING, LOW GRADE FEVER, AND MALODOR FROM THE SPINAL INCISION SITE. ONE WEEK LATER, THE PATIENT HAD CHANGED HER BANDAGE AT HOME AND NOTICED THE PUS SATURATED THE ENTIRE BANDAGE. THE PATIENT WAS INSTRUCTED TO COME DIRECTLY TO THE ER, WAS ADMITTED THAT DAY AS AN INPATIENT, AND STARTED ON A REGIMEN OF INTRAVENOUS ANTIBIOTICS AFTER A CULTURE AND SENSITIVITY WAS OBTAINED. IT WAS NOTED THAT THE PATIENT WAS GOING TO HAVE HER CATHETER/PUMP SYSTEM EXPLANTED TWO DAYS LATER. ANOTHER CULTURE AND SENSITIVITY WAS OBTAINED, AND THE PATIENT'S ARMS AND LEGS WERE NOTED TO BE HYPERTONIC. THE CLINICIANS "FELT IT DOUBTFUL THE PATIENT WAS RECEIVING THE DOSE OF MEDICATIONS" DUE TO THE CSF LEAK. INTRAOPERATIVELY, PUS WAS NOTED AT THE PUMP POCKET SITE AND THE CLINICIANS FELT THE INFECTION AT THE SPINAL SITE HAD TRACKED TO THE PUMP POCKET SITE. THE PATIENT REMAINED HOSPITALIZED POST-OPERATIVELY TO ASSESS FOR POTENTIAL BACLOFEN WITHDRAWAL AND TO CONTINUE INTRAVENOUS ANTIBIOTICS. THE PUMP WAS AVAILABLE FOR ANALYSIS ABOUT ONE MONTH LATER THAN THE CATHETER, AND A FOLLOW-UP REPORT WILL BE GENERATED WHEN PUMP ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    A CATHETER OCCLUSION WAS REPORTED. THE PATIENT REQUIRED INCREASING PUMP INFUSION RATES WITHOUT ANY THERAPEUTIC EFFECT. AN X-RAY WAS DONE IN (B)(6) 2012, WHICH INDICATED ADHESIONS. INTRAOPERATIVELY, IT WAS NOTED THERE WAS NO RETROGRADE FLOW OF CEREBRAL SPINAL FLUID WHEN THE CATHETER WAS DISCONNECTED FROM THE PUMP. WHEN THE SPINAL AND PUMP CATHETERS SEGMENTS WERE DISCONNECTED, A SINGLE BOLUS WAS PROGRAMMED AND THEN ABORTED AFTER FLUID WAS VISUALIZED AT THE DISTAL TIP OF THE PROXIMAL (PUMP) SEGMENT. DISTAL CATHETER WAS REPLACED. THE DEVICE SYSTEM WAS USED TO INFUSE GABLOFEN. PATIENT OUTCOME WAS NOTED AS ALIVE WITH NO INJURY/ADVERSE EVENT. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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