BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3953734 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13455
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT # J0177998R, PRODUCT TYPE CATHETER; PRODUCT ID 8578, LOT # N084297, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS OF THE PUMP FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VOLUME DISCREPANCY OCCURRED DURING A PROCEDURE; THE EXPECTED RESIDUAL VOLUME (ERV) WAS 13ML WHILE THE ACTUAL RESIDUAL VOLUME (ARV) WAS 17ML. ACTIONS REQUIRED AS A RESULT OF THE EVENT CONSISTED OF REPLACEMENT. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT AND THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS UNABLE TO BE OBTAINED. THE PUMP WAS TO BE RETURNED. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS ALSO REPORTED THE ARV HAD BEEN 17ML AND THE ERV HAD BEEN 13.1ML. IT WAS REPORTED THE PUMP HIT ERI (ELECTIVE REPLACEMENT INDICATOR) AND DURING THE PUMP REPLACEMENT, THEY DISCOVERED THE DISCREPANCY WHILE ASPIRATING THE OLD DRUG OUT OF THE PUMP. THERE HAD BEEN NO REPORT OF SYMPTOM CHANGE AND NO REPORTS OF STALLS IN THE LOGS. THE CATHETER WAS ASPIRATED AND DYE WAS INJECTED INTO THE CATHETER AND THE FLOW AS GREAT. THE DYE WENT INTO THE IT (INTRATHECAL) SPACE. IT WAS FURTHER REPORTED THE PATIENT CAME TO THE HEALTH CARE PROVIDER (HCP) FACILITY ON (B)(6) 2014 DUE TO AN INCREASE IN PAIN AND SPASMING. THE ONSET WAS UNKNOWN TO THE HCP AND IT WAS NOTED THE PATIENT IS NON-VERBAL. IT WAS ALSO REPORTED THE PATIENT HAD THE PUMP REPLACED DUE TO A ¿DEPLETED BACLOFEN PUMP¿. IT WAS LATER REPORTED THE TYPE OF BACLOFEN WAS LIORESAL. IT WAS FURTHER REPORTED THE CAUSE FOR THE VOLUME DISCREPANCY WASN¿T IDENTIFIED. THE PATIENT WAS STILL UNDER SEDATION AT THE CONCLUSION OF THE CASE SO THE DEVICE MANUFACTURER REPRESENTATIVE WAS UNABLE TO TALK WITH HER. IT WAS LATER REPORTED THE DAILY DOSE OF THE BACLOFEN HAD BEEN 1,096 PER 24 HOURS AT A CONCENTRATION OF 2,000MCG. OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT INCLUDED ORAL BACLOFEN. THE PATIENT REPORTEDLY HAD AN INCREASE IN SPASTICITY WITH NO OTHER CAUSE FOUND. IN TERMS OF WHAT THE CAUSE OF THE EVENT WAS, IT WAS REPORTED ¿? IF PUMP BEGAN TO FAIL FOUR MONTHS BEFORE BATTERY LIFE EXPIRES.¿ THE EVENT WAS ATTRIBUTED TO THE PUMP. IT WAS ALSO REPORTED CATHETER ASSESSMENT SHOWED IT WAS INTACT AND THEN IT WAS DECIDED TO REPLACEMENT PUMP SINCE IT WAS AT ITS END OF BATTERY LIFE. IN TERMS OF PATIENT OUTCOME, THE PATIENT WAS ¿JUST POST-OP¿ AT THE TIME OF THE REPORTED INFORMATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431048 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention