BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2881646 · Received December 20, 2012

    Report

    Report Number
    3007566237-2012-03072
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

    ALL PREVIOUSLY REPORTED PATIENT CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4). THE PREVIOUSLY REPORTED CONCLUSION CODE(S) NO LONGER APPLIES TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A POCKET FILL OCCURRED. IT WAS NOTED THAT "MOST" OF THE 20MLS "LIKELY" WENT INTO THE POCKET; THE HEALTH CARE PROVIDER (HCP) WAS "ONLY ABLE TO ASPIRATE "APPROXIMATELY" 2MLS FROM THE PUMP." THE PATIENT FELT A BURNING "SHORTLY" AFTER THE FILL AND WAS "HIGH AS A KITE." IT WAS REPORTED THE PATIENT WENT TO ULTRASOUND TO "SEE IF THERE WAS FLUID IN THE POCKET," NO RESULTS WERE REPORTED. THREE HOURS AFTER POCKET FILL, PATIENT WAS "BROUGHT TO CRITICAL CARE AND GIVEN OXYGEN FOR APNEA EPISODES," WHICH THE PATIENT "USED TO" HAVE WHEN SHE TOOK "ORALS." IT WAS NOTED THAT THE PATIENT WAS TO BE MONITORED "FOR A FEW MONTHS." AT THE TIME OF THIS REPORT NO PATIENT OUTCOME WAS NOTED. THE DEVICE SYSTEM WAS USED TO INFUSE BUPIVACAINE, AND DILAUDID. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET FILL. THE PATIENT HAD AN ULTRASOUND (B)(6) 2012 THAT SHOWED NO APPRECIABLE COLLECTION. THE PATIENT EXPERIENCED PAIN AT THE PUMP SITE, ANXIETY, AND HYPERTENSION. THE PATIENT WAS OBSERVED IN THE INTENSIVE CARE UNIT (ICU) FOR 24 HOURS. THE PATIENT OUTCOME WAS NO INJURY. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization