BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3872249 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11560
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ¿SOME ISSUES¿ WITH A GRANULOMA AT THE SITE OF THE CATHETER AND THE PUMP MAY BE REPLACED SOON. THE PATIENT HAD AN MRI WITHIN THE LAST MONTH, BUT THE REPORTER DID NOT KNOW THE SPECIFIC DATE. THE HEALTHCARE PROVIDER (HCP) DID AN EXTENSIVE NEUROLOGICAL TEST ON (B)(6) 2014 AND TOOK NOTES. THE PATIENT HAD A FOLLOW-UP APPOINTMENT SCHEDULED FOR EITHER THE WEEK FOLLOWING THIS REPORT OR THE NEXT WEEK. THE REPORTER WAS NOT SURE OF THE DATE. THE HCP PLANNED TO DO ANOTHER MRI IN A FEW WEEKS TO A MONTH¿S TIME. IF NO CHANGE WAS SEEN, THE HCP MAY REFER THE PATIENT TO A NEUROSURGEON. THE PATIENT EXPERIENCED INCREASED SYMPTOMS OF PAIN IN THE LAST COUPLE OF MONTHS, PRIOR TO A DIAGNOSIS WITH THE MRI. THE GRANULOMA WAS SLIGHTLY TO THE LEFT OF THE SPINAL CORD. THE HCP FELT THIS WAS WHY THE PATIENT¿S LEFT LEG HAD TREMENDOUS INCREASED SCIATICA, AS WELL AS WEAKNESS IN HIS LEFT LEG. THE PATIENT ALERTED HIS NURSE TO THE INCREASED PAIN DURING REFILLS AND THE NURSE ALERTED THE HCP. THE HCP THEN BEGAN TO ASSESS THE PATIENT MORE CLOSELY. IN (B)(6) 2014, THE PATIENT¿S DOSE HAD BEEN CUT BY 50% ON 3 DIFFERENT VISITS. AT THIS TIME, THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE, FENTANYL CITRATE AND KETAMINE. AT THE TIME OF THIS REPORT, THE PATIENT HAD A FENTANYL PATCH AND ORAL MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350215 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Other