BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2862506 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11292
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 7, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE INFUSION PUMP REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND. THE CATHETER WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, LOT# UNK. PRODUCT TYPE: CATHETER: PRODUCT ID 8596, LOT# UNK, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PAST SUMMER THE PATIENT PRESENTED WITH A RETURN OF SPASTICITY. PATIENT EXPERIENCED "SOME WITHDRAWAL" WHICH TRIGGERED AUTONOMIC DYSREFLEXIA. AN X-RAY WAS PERFORMED WHICH DID NOT REVEAL ANY ISSUES. CT SCAN WITH CONTRAST DYE WAS PERFORMED AND REVEALED A CATHETER LEAK. THE PATIENT WAS STARTED ON ORAL BACLOFEN. A REVISION WAS DONE AND THE CATHETER WAS REPLACED ON (B)(6) 2012. THE PUMP WAS DELIVERING BACLOFEN. ADDITIONAL INFORMATION WAS REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS STATED THAT DURING THE CT SCAN, EXTRAVASATION OF THE DYE WAS SEEN AROUND THE 3RD LUMBAR VERTEBRA. IT WAS FOUND THAT THE ORIGINAL SPINAL SEGMENT AND THE LUMBAR SEGMENT OF THE CATHETER HAD MIGRATED INTO THE PATIENT'S FLANK. NORMALLY, THIS SEGMENT WOULD HAVE BEEN SUTURED IN THE LUMBAR FASCIA, BUT HAD MIGRATED AND CREATED TENSION AT THE LEVEL OF THE ANCHOR. A SMALL HOLE WAS CREATED WHERE THE SPINAL CATHETER HAD BEEN KINKED AND WAS RUBBING ON THE ANCHOR CONNECTOR. THE PHYSICIAN TRIMMED THE CATHETER AT THE LEVEL OF THE HOLE AND CONNECTED IT TO A NEW PORTION OF CATHETER. ADDITIONALLY, THE PATIENT'S PUMP WAS EXPLANTED AS THE BATTERY WAS CLOSE TO IT'S END-OF-LIFE. AT THE TIME OF REPORT, THE PATIENT HAD RECOVERED "BEAUTIFULLY" AND WAS DOING "FINE". IT WAS REPORTED THAT THE SPECIFIC BACLOFEN USED IN THIS SYSTEM WAS LIORESAL.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention