BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3092539 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07282
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 8, 2013
    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, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: CATHETER: PRODUCT ID 8 590-1, LOT# N247208, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013 A KIDNEY/URETER/BLADDER (KUB) X-RAY WAS PERFORMED AND THE RESULT WAS INCONCLUSIVE WITH REGARD TO THE CONTINUITY OF THE CATHETER FROM THE PUMP TO THE SPINAL CANAL. THE HCP DID NOT KNOW WHAT SYMPTOMS THE PATIENT WAS EXPERIENCING AT THE TIME. ON (B)(6) 2013 THE PATIENT SAW HIS PRIMARY CARE PHYSICIAN BECAUSE HE WASN'T FEELING WELL AND HAVING UNUSUAL SYMPTOMS. AN ABDOMINAL ULTRASOUND WAS PERFORMED AND AGAIN THE CONTINUITY OF THE CATHETER COULD NOT BE CONFIRMED. DRUG DELIVERED VIA THE DEVICE WAS LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IT WAS LATER REPORTED THAT THE PATIENT TRAVELLED TO SEE HIS REFILL PHYSICIAN WHO SUSPECTED A CATHETER LEAK. THE REFILL PHYSICIAN WAS UNABLE TO PERFORM A CATHETER DYE STUDY AS HE WAS NOT TRAINED ON THE PROCEDURE AND DID NOT HAVE A FLUOROSCOPY SUITE IN HIS OFFICE. THE PATIENT WAS PLACED ON ORAL BACLOFEN TO PREVENT WITHDRAWAL. IT WAS NOTED THAT AT THE PREVIOUS REFILL THE DOSAGE WAS INCREASED BY 5% AS THE PATIENT WAS HAVING WORSENED SPASTICITY THOUGH THE PHYSICIAN THOUGHT THE SYMPTOMS COULD ALSO BE DUE TO A URINARY TRACT INFECTION. AFTER THAT APPOINTMENT THE PATIENT CONTINUED TO EXPERIENCE SPASTICITY, ALONG WITH ABDOMINAL PAIN, NAUSEA, AND A RASH. THE REFILL PHYSICIAN WAS TRYING TO LOCATE A PHYSICIAN TO TEST THE PUMP SYSTEM BUT WAS HAVING DIFFICULTY DUE TO THE PATIENT'S INSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193890 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1