BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2678329 · Received August 1, 2012

    Report

    Report Number
    3004209178-2012-06359
    Event Type
    Injury
    Date Received
    August 1, 2012
    Report Date
    July 5, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8731 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), EXPLANTED: PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT POSSIBLY EXPERIENCED WITHDRAWAL SYMPTOMS AFTER THE DOSE REDUCTION IN THE HOSPITAL, HOWEVER THE MANUFACTURER REPRESENTATIVE COULD NOT EXACTLY RECALL WHAT HAPPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL OCCURRED DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). IT WAS REPORTED THAT THE PUMP WAS WORKING PROPERLY. IT WAS REPORTED THAT THE PATIENT ARRIVED AT THE ER WITH SYMPTOMS OF EXTREME SOMNOLENCE AND UNRESPONSIVENESS. THE EMERGENCY ROOM (ER) PHYSICIAN PURPOSELY INDUCED MOTOR STALL BY TAPING A MAGNET OVER THE PUMP SITE. WHEN THE MANUFACTURER REPRESENTATIVE ARRIVED, THE PATIENT HAD BEEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND HAD BEEN GIVEN A NARCAN DRIP AND WAS AT THE TIME "IMPROVING" AND WAS "MUCH MORE RESPONSIVE". THE REPORTER HAD HEARD THE PATIENT COMPLAIN OF PAIN SEVERAL TIMES. THE MANUFACTURER REPRESENTATIVE ALERTED THE MD INTERN THAT THE PUMP WOULD HAVE TO BE REMOVED IN ORDER TO INTERROGATE, AND INFUSION WOULD LIKELY RESUME AFTER REMOVAL. UPON INTERROGATION, THE MOTOR STALL DID APPEAR IN THE LOGS AND IT HAD "APPARENTLY" OCCURRED AT THE ESTIMATED TIME THAT THE MAGNET WAS TAPED ON. IT WAS NOTED THAT APPROXIMATELY TEN MINUTES LATER THE LOGS REVEALED MOTOR STALL RECOVERY. A DECISION TO RESUME SIMPLE CONTINUOUS INFUSION BUT TO REDUCE THE PATIENT'S DOSE WAS MADE. THE PATIENT HAD PREVIOUSLY BEEN PROGRAMMED AT 5MG/DAY DILAUDID (ALONG WITH CORRESPONDING BUPIVACAINE AND CLONIDINE), WITH A PERSONAL THERAPY MANAGER (PTM) DOSE OF 0.25MG (3 DOSES ALLOWED PER DAY); HOWEVER, THE LOGS SHOWED THAT THE PTM HAD NOT BEEN USED SINCE THE LAST INTERROGATION WHICH WAS BELIEVED TO BE "MANY DAYS" PRIOR TO THE EVENT. THE SIMPLE CONTINUOUS DOSE WAS REDUCED TO 4MG/DAY. IT WAS REPORTED THAT THE PUMP WAS NOT DETERMINED TO BE THE CAUSE OF THE EVENT AND THAT NO ABNORMAL FUNCTION OF THE PUMP WAS DETECTED. THE PATIENT OUTCOME WAS REPORTED AS ALIVE BUT WITH INJURY. THE MEDICATION CONCENTRATIONS WERE DILAUDID 10MG/ML, BUPIVACAINE 40MG/ML, AND CLONIDINE 100MCG/ML. THE PATIENT LATER STATED THAT SHE WENT INTO THE HOSPITAL AND THEY "ACCIDENTALLY" TURNED HER PUMP OFF WITH A MAGNET. THE PATIENT STATED THAT THE MANUFACTURER REPRESENTATIVE MET HER ON (B)(6) 2012 AND STARTED THE PUMP AGAIN, AND THAT SHE WENT HOME FROM THE HOSPITAL ON THE FOLLOWING SATURDAY. THE PATIENT ALSO STATED THAT SHE WAS IN A LOT OF PAIN AND NEEDED TO KNOW HOW TO WORK HER PTM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R