BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2982810 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03155
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    January 31, 2013
    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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS REVEALED THAT THE PUMP PASSED ALL NON-DESTRUCTIVE TESTING AND NO ANOMALIES WERE NOTED IN PUMP LOGS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO ACCESS THE CATHETER ACCESS PORT (CAP) IN THE CLINIC HOWEVER, ASPIRATION WAS UNSUCCESSFUL. IN ADDITION, THERE WAS SIGNIFICANTLY MORE DRUG THAN SHOULD BE IN THE RESERVOIR AT REFILL. THE PUMP POCKET WAS OPENED IN SURGERY, THE CATHETER WAS DISCONNECTED FROM THE EXISTING PUMP AND WAS ASPIRATED WITHOUT DIFFICULTY. THE CATHETER WAS RECONNECTED TO THE PUMP AND THE CAP WAS ASPIRATED WITHOUT DIFFICULTY. SINCE THE CATHETER APPEARED TO BE FUNCTIONING NORMALLY THE PHYSICIAN ELECTED TO REPLACE THE PUMP AND RETURN IT FOR ANALYSIS. THE CATHETER WAS LEFT INTACT CONNECTED TO THE NEW PUMP. NO INJURY PATIENT INJURY OR NO ADVERSE EVENT OCCURRED. THE PATIENT DID EXHIBIT INCREASED SPASTICITY IN ALL FOUR EXTREMITIES. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION PREVIOUSLY REPORTED IN THIS MANUFACTURER REPORT WILL NOW BE REPORTED UNDER MANUFACTURER REPORT # 3004209178-2013-07654. [AFTER THE PUMP REPLACEMENT PREVIOUSLY REPORTED, THE PATIENT WOKE UP FROM SURGERY AND WAS BACK TO A FUNCTIONAL LEVEL FOR AT LEAST 5 HOURS. THE PATIENT'S DOSE POST-SURGERY WAS 100 MCG/D. WITHIN 15 MINUTES, IT WAS REPORTED THAT THE PATIENT WENT FROM TALKING TO SEVERE SEIZURES. THE PATIENT DID NOT HAVE ANY INCREASE IN SPASMS, TONE, OR REPORTS OF ITCHING. THE NEUROSURGERY TEAM REPORTED THE PATIENT HAD ACUTE RESPIRATORY DISTRESS SYNDROME AND THE PATIENT HAD A TRACH PLACED. THE TEAM EVALUATED THE PATIENT'S SYMPTOM PRESENTATION AS A POSSIBLE WITHDRAWAL, BUT IT WAS RULED OUT. THE PATIENT WAS ALMOST TO A THERAPEUTIC DOSE NOW AT APPROXIMATELY 300 MCG/D].

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT PRIOR TO THE REVISION SURGERY THE PATIENT HAD A LACK OF RESPONSE TO THE THERAPY AT 700 MCG/D. THERE WAS NO FLOW THROUGH THE CATHETER ACCESS PORT. AFTER THE PUMP REPLACEMENT PREVIOUSLY REPORTED, THE PATIENT WOKE UP FROM SURGERY AND WAS BACK TO A FUNCTIONAL LEVEL FOR AT LEAST 5 HOURS. THE PATIENT'S DOSE POST-SURGERY WAS 100 MCG/D. WITHIN 15 MINUTES, IT WAS REPORTED THAT THE PATIENT WENT FROM TALKING TO SEVERE SEIZURES. THE PATIENT DID NOT HAVE ANY INCREASE IN SPASMS, TONE, OR REPORTS OF ITCHING. THE NEUROSURGERY TEAM REPORTED THE PATIENT HAD ACUTE RESPIRATORY DISTRESS SYNDROME AND THE PATIENT HAD A TRACH PLACED. THE TEAM EVALUATED THE PATIENT'S SYMPTOM PRESENTATION AS A POSSIBLE WITHDRAWAL, BUT IT WAS RULED OUT. THE PATIENT WAS ALMOST TO A THERAPEUTIC DOSE NOW AT APPROXIMATELY 300 MCG/D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87577 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention