BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3061978 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06388
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 18, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND SIGNIFICANT DAMAGE TO THE RESERVOIR SEPTUM WHILE IMPLANTED. IT WAS NOTED THE SEPTUM WAS NOT FOUND TO BE LEAKING. THE PUMP PASSED DISPENSE ACCURACY TESTING AND NO OVER INFUSION, DISCREPANCIES OR LEAKS WERE FOUND. THE FILL SEPTUM WAS INSPECTED AND DAMAGE WAS FOUND. THE CONDITION OF THE SEPTUM INDICATED THE POSSIBILITY OF THE USE OF A NON-MEDTRONIC NEEDLE TO FILL THE PUMP. IT WAS NOTED IT WAS ALSO POSSIBLE THAT THE SEPTUM MATERIAL (SILICONE) COULD HAVE RE-SEALED ITSELF AND NO LEAKING COULD BE FOUND DURING ANALYSIS.

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# SERIAL# UNKNOWN, IMPLANTED: 2006 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT SHOWED WITHDRAWAL SYMPTOMS AND DYSTONIC PAIN. THIS PATIENT ALSO EXPERIENCED INCREASED SPASTICITY AND UNSPECIFIED UNDERDOSE SYMPTOMS. A FEW DAYS AFTER, THE PATIENT RETURNED TO THE HOSPITAL AND THE PHYSICIAN PROVIDED ONE OR MORE SINGLE BOLUS OF DRUGS (100 MICROGRAMS EACH). ON (B)(6) 2013, THE PHYSICIAN ATTEMPTED TO ASPIRATE FROM THE CATHETER ACCESS PORT (CAP) AND ALL WAS "OK." THE X-RAY WAS ALSO "OK." HOWEVER, THE PATIENT DID NOT SHOW SYMPTOMS OF IMPROVEMENT. IT WAS DECIDED TO REFILL THE PUMP. THE EXPECTED VOLUME WAS 12 MILLILITERS (ML), HOWEVER, THE PUMP WAS EMPTY. IT WAS SUSPECTED THAT PERHAPS AT IMPLANT THE PUMP HAD NOT BEEN REFILLED CORRECTLY. THE PUMP WAS NOW SUCCESSFULLY REFILLED WITH BACLOFEN 2000 MICROGRAMS/ML AND A CONFIRMED DOSAGE OF 850 MICROGRAMS/DAY. THE THERAPEUTIC EFFECT WAS RECOVERED AND THE PATIENT DID "WELL." HOWEVER, AFTER A FEW DAYS, THE DOSAGE WAS REDUCED TO 250 MICROGRAMS/DAY AS THE PATIENT WAS VERY FLACCID. THE PATIENT WAS SEEN ON (B)(6) 2013 AND WAS "FINE." HOWEVER, ON (B)(6) 2013, THE PATIENT ARRIVED AT THE HOSPITAL IN A WITHDRAWAL STATE AND THE RESERVOIR WAS EMPTY AGAIN. REPORTEDLY AT THE FIRST NOTIFICATION, THE PHYSICIAN HAD ASSURED THAT THE CALIBRATION WAS CONSTANT AS IT WAS ALWAYS CHECKED BEFORE IMPLANTING. IN ADDITION, THE PHYSICIAN REMEMBERED THAT THERE WAS A LOT OF PRESSURE AT THE FIRST REFILL OF THE PUMP AND THE SYRINGE PISTON WAS PUSHED IN ORDER TO EXCEED THE OPPOSITION OF THE PUMP. THE PATIENT HAD NOT USED HEAT THERAPY AND THERE WAS NOT A PERSONAL THERAPY MANAGER (PTM) INVOLVED WITH THIS EVENT. ALTHOUGH THE REFILLS HAD BEEN PERFORMED WITHOUT A MEDTRONIC REPRESENTATIVE PRESENT, REPORTEDLY IT WAS THOUGHT THAT A MEDTRONIC REFILL KIT WAS USED FOR THE REFILL. A POCKET FILL WAS EXCLUDED AS IT REPORTEDLY WOULD HAVE BEEN EASILY DETECTED AS THE PEDIATRIC PATIENT WAS VERY THIN. ULTIMATELY, THE PUMP WAS EXPLANTED ON (B)(6) 2013 AND A NEW DEVICE WAS IMPLANTED. THE PHYSICIAN ELECTED TO EXPLANT THE PUMP AS A MALFUNCTION WAS SUSPECTED, BUT THE REASON WAS NOT KNOWN. THERE WAS INQUIRY IF PUSHING THE SYRINGE PISTON COULD HAVE DAMAGED THE PRESSURE VALVE. THE PATIENT REQUIRED HOSPITALIZATION. THIS DEVICE SYSTEM DELIVERED LIORESAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT HAD TAKEN PLACE FOLLOWING A NORMAL PUMP REPLACEMENT. FOLLOWING THE REPLACEMENT, IT WAS REPORTED THE HEALTH CARE PROVIDER HAD 'NOT BEEN SURE IF HE HAD FILLED THE DRUG RESERVOIR WITH THE DRUG' HOWEVER IT WAS LATER REPORTED A POCKET FILL HAD BEEN EXCLUDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTH CARE PROVIDER (HCP) USUALLY DID NOT USE THE MANUFACTURER REFILL KIT TO FILL THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162527 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R