BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3950721 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13369
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    May 29, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER FOUND A SIGNIFICANT ANOMALY. THE CATHETER BODY WAS FOUND TO BE BROKEN ON THE PROXIMAL SIDE. IT WAS NOTED THAT THERE WERE AREAS THAT APPEARED TO HAVE BEEN COMPRESSED AROUND THE BREAK.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION DETERMINED THE FOLLOWING: PATIENT IS ALSO RELATED TO THIS EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE FATIGUE SECONDARY TO CLONIDINE WAS REPORTEDLY RESOLVED WITHOUT SEQUALAE AT ON (B)(6) 2014. IT WAS NOTED THAT THE SYMPTOMS WERE LIKELY RELATED TO EITHER THE INTRATHECAL MEDICATION (HYDROMORPHONE AND BUPIVACAINE), OR LACK OF INFUSION. IT WAS NOTED THAT THE DEVICE WAS DISPOSED OF ACCORDING TO BIOHAZARD INSTRUCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABNORMAL AND INTERMITTENT LOWER EXTREMITY WEAKNESS. THE SEVERITY WAS REPORTED TO BE MILD AS IT DID NOT INTERFERE IN A SIGNIFICANT MANNER WITH THE PATIENT'S NORMAL FUNCTIONING LEVEL. THE EVENT WAS REPORTEDLY ONGOING. THE PUMP WAS BEING USED TO DELIVER DILAUDID, CLONIDINE, AND BUPIVACAINE. THE PATIENT WAS REPORTEDLY EXPERIENCING ABNORMAL FATIGUE AND DIFFICULTY STAYING AWAKE ON (B)(6) 2014. THE CLINICAL DIAGNOSIS WAS FATIGUE SECONDARY TO INTRATHECAL CLONIDINE. THE SEVERITY WAS REPORTED AS MILD. THE PUMP WAS REPORTEDLY REPROGRAMMED ON (B)(6) 2014 AND REFILLED WITHOUT CLONIDINE ON (B)(6) 2014. THE PATIENT WAS REPORTEDLY ADMINISTERED WITH A SAMPLE OF NUVIGIL 150 MG ON (B)(6) 2014. IT WAS REPORTED THAT THE ABNORMAL LOWER EXTREMITY WEAKNESS WAS RELATED TO THE INTRATHECAL MEDICATION BUPIVACAINE. THE EVENT REPORTEDLY RESOLVED WITHOUT SEQUELAE FROM THE WEAKNESS ON (B)(6) 2014. THE EVENT WAS REPORTEDLY STILL ONGOING. IT WAS FURTHER REPORTED ON (B)(6) 2014 THE PATIENT REPORTED EPISODES OF SEVERE LOWER EXTREMITY NUMBNESS AND INTERMITTENT PARALYSIS OF THEIR LOWER EXTREMITIES. THE PATIENT ALSO REPORTED THE EPISODES OCCURRED DAILY, WERE UNPREDICTABLE AND RESOLVED WITHIN HOURS. THE SEVERITY WAS LISTED AS MODERATE INDICATING IT PRODUCED SOME IMPAIRMENT OF FUNCTIONING BUT WAS NOT HAZARDOUS TO HEALTH. AS A RESULT, AN UNSCHEDULED CLINIC OR OFFICE VISIT OCCURRED AND THE PUMP WAS REPROGRAMMED ON (B)(6) 2014. A FIBROUS SHEATH WAS COVERING THE TIP OF THE CATHETER WAS SEEN FROM AN MRI WITH CONTRAST ON (B)(6) 2014. A REVISION THEN OCCURRED, AND DURING THE REVISION THE HEALTH CARE PROVIDER (HCP) OBSERVED A CATHETER LEAK INSIDE THE INTRATHECAL SPACE AND CATHETER KINK. IT WAS NOTED THE INTERMITTENT PARALYSIS WAS LIKELY SECONDARY TO THE LEAKING CATHETER IN THE LUMBAR SPINE WITH EXPOSURE TO BUPIVACAINE. THE CATHETER WAS EXPLANTED AND REPLACED. THE EVENT WAS LISTED AS ONGOING AS OF (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CLINICAL STUDY. IT WAS NOTED THAT THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A CLINICAL STUDY. IT WAS REPORTED THAT ETIOLOGY WAS RELATED TO ENTIRE CATHETER. CLINICAL DEVICE DIAGNOSIS INCLUDED CATHETER LEAKAGE AND PARESTHESIA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE THERAPY RELATED EVENT, DEVICE DIAGNOSIS WAS CHANGED TO ¿NOT APPLICABLE.¿ THE DEVICE DIAGNOSIS WAS CHANGED TO ¿BLANK.¿ THE THERAPY RELATED EVENT, CLINICAL DIAGNOSIS WAS CHANGED TO ¿CATHETER TIP FIBROSIS WITH LOWER EXTREMITY NUMBNESS AND INTERMITTENT PARALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428872 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention