BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3900617 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12225
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER CONNECTOR PIN FOUND THE COLLECT FINGERS TO BE BENT/DAMAGED/FOLDED OUT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED A MEDICAL OR NON-SURGICAL THERAPY ACTION WAS TAKEN; 330CCS OF FLUID WERE ASPIRATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SEROMA AT THE PUMP POCKET AND CATHETER INCISION SITE. THE PATIENT HAD ITCHING AT THE PUMP SITE AND DISCOMFORT AT THE INCISION SITE. THE PUMP POCKET SEROMA WAS ASPIRATED, AND THE CATHETER INCISION SITE SEROMA WAS DRAINED. THE CONNECTING PIN WAS REPLACED. THE PATIENT WAS ADMINISTERED ORAL BENADRYL FOR ITCHING. A CATHETER ACCESS PORT (CAP) STUDY WAS PERFORMED AND FOUND THE CATHETER CONNECTOR WAS OCCLUDED. THE DRUG IN THE PUMP WAS UNKNOWN. THE EVENT WAS NOTED TO BE "ONGOING". IT WAS FURTHER REPORTED THE PATIENT HAD PAIN AND ITCHING AT PUMP SITE. IT WAS FURTHER REPORTED THE PUMP CONTAINED MORPHINE, BUPIVACAINE, CLONIDINE AND COMPOUNDED BACLOFEN. IT WAS FURTHER REPORTED THE PATIENT HAD A CEREBROSPINAL FLUID (CSF) LEAK AND A HEADACHE. A EPIDURAL BLOOD PATCH WAS PERFORMED AND FLUID AND CAFFEINE INTAKE WERE INCREASED. THE EVENT WAS NOTED TO HAVE RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT 220 CC OF FLUID WAS REPORTEDLY ASPIRATED ON (B)(6) 2014. THE PATIENT REPORTEDLY RECOVERED WITHOUT SEQUELAE ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT DEVICE DIAGNOSIS WAS CATHETER LEAKAGE. THE PATIENT HAD PRESENTED FOR A PUMP REFILL ON (B)(6) 2014. THE INTERROGATED RESERVOIR VOLUME WAS 2.8ML BUT GREATER THAN 16ML WAS ASPIRATED. THE PLAN WAS FOR A CATHETER REVISION OF THE CATHETER "LUMBAR/PUMP PORTION" AND "BROKEN CONNECTING PIN." ON (B)(6) 2014 THERE WAS A SURGICAL INTERVENTION WHERE THE CONNECTING PIN WAS REPLACED AND THE CATHETER WAS RE-ANCHORED. IT WAS REPORTED THAT THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT, ON (B)(6) 2014, THE SEROMA WORSENED. ON THE SAME DATE, 200ML OF FLUID WAS ASPIRATED. AT THIS TIME, THE EVENT STATUS WAS ONGOING OR UNRESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT RESOLVED WITHOUT SEQUELA ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A NEW COLLET WAS USED TO REATTACH WHERE THE CATHETER WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377932 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention