BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3233258 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11945
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    January 28, 2013
    Report Date
    April 19, 2017
    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
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8575, LOT # J0206287R, IMPLANTED: (B)(6) 2005, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    REFERENCES THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. PRODUCT ID: 8575, LOT# J0206287R, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    FRIENDS/FAMILY REPORTED A PUMP PROBLEM. CALLER REPORTS THAT AS A RESULT OF THE PUMP UNAPPROVED DRUGS-RECALL, HER HCP DECIDED TO TRY TO DECREASE THE MED IN PUMP. PT IS CURRENTLY DOWN 30% FROM HIS USUAL DOSAGE AND IN EXTREME PAIN AND AGONY. CALLER REPORTS THAT HE HAS 9 DISCS OUT IN HIS BACK AS WELL AS PROBLEMS IN THE CERVICAL AREA. CALLER STATES THAT THE PUMP GAVE THE PATIENT HIS LIFE BACK (WITHIN CERTAIN LIMITS) AND THEY ARE AFRAID OF LOSING THE PUMP AS A THERAPY OPTION. DRUGS: BUPIVACAINE AND DILAUDID (HYDROMORPHONE). ADDITIONAL INFORMATION RECEIVED, PER COMMUNICATION FROM THE PATIENT¿S LEGAL REPRESENTATIVE, ALLEGES THAT THE PUMP CAUSED THE PATIENT HARM IN 2013, THAT IT WAS EXPLANTED IN (B)(6) 2013, AND THAT IT ¿CONTINUES TO CAUSE HIM HARM THROUGH THE PRESENT.¿ THE DEVICE CAUSED HIM PERSONAL INJURY INCLUDING ¿PUMP MALFUNCTION REQUIRING MEDICAL INTERVENTION, CATHETER PROBLEMS, MANUFACTURING DEFECTS AND/OR OTHER DEFECTIVE WARNINGS CONCERNING THE DEVICES.¿

    Description of Event or Problem · 1

    THE NARRATIVE REPORTED IN MANUFACTURER REPORT # 3004209178-2013-11945 IS BEING UPDATED TO THIS: IT WAS REPORTED THAT THE DEVICE WAS USED TO INFUSE DILAUDID AND BUPIVACAINE AND BECAUSE OF READING ABOUT THE UNAPPROVED DRUGS- RECALL THE HEALTHCARE PROVIDER (HCP) AND THE PATIENT¿S FAMILY DECIDED TO DECREASE THE MEDICATION IN THE PUMP, AS THE PATIENT AND HIS WIFE WERE CONCERNED ABOUT OVERDOSE IF THE DEVICE WERE TO EXPERIENCE A MOTOR STALL.. AT THE TIME OF THE INITIAL REPORT, THE PATIENT WAS IN ¿AT 30% LESS THAN HE WAS¿ (NO DOSES OR CONCENTRATIONS WERE REPORTED.) IT WAS NOTED HE WAS ¿SUPPOSED TO GO DOWN ANOTHER 10 PERCENT¿ THE FOLLOWING DAY, WHICH THE REPORTED DID NOT THINK WAS GOING TO HAPPEN BECAUSE THE PATIENT WAS IN PAIN. IT WAS STATED ¿HE¿S GOT NINE LEVELS OF HIS SPINE BLOWN AND THREE IN HIS NECK. HE¿S IN AGONY WITH THE PUMP AND IT¿S INOPERABLE. YOU CAN¿T FIX THAT MANY LEVELS, YOU KNOW. SO, YOU KNOW, IT¿S, LIKE, AT THIS POINT, AT 30 PERCENT, HE¿S BACK TO PAIN LEVEL THAT IS NOT ACCEPTABLE WITHOUT AN ORAL MED ADDITION, YOU KNOW, AND THAT¿S NOT GOING TO HAPPEN.¿ ADDITIONAL INFORMATION RECEIVED, PER COMMUNICATION FROM THE PATIENT¿S LEGAL REPRESENTATIVE, ALLEGES THAT THE PUMP CAUSED THE PATIENT HARM IN 2013, THAT IT WAS EXPLANTED IN (B)(6) 2013, AND THAT IT ¿CONTINUES TO CAUSE HIM HARM THROUGH THE PRESENT.¿ THE DEVICE CAUSED HIM PERSONAL INJURY INCLUDING ¿PUMP MALFUNCTION REQUIRING MEDICAL INTERVENTION, CATHETER PROBLEMS, MANUFACTURING DEFECTS AND/OR OTHER DEFECTIVE WARNINGS CONCERNING THE DEVICES.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 FROM A LEGAL FIRM INDICATED DELIVERY FAILURE, PUMP FAILURE AND CATHETER FAILURE HAD OCCURRED. NO EVENT DATE WAS SPECIFIED. THE PATIENT EXPERIENCED OVERDOSE. THE PUMP INDICATION FOR USE WAS NON-MALIGNANT PAIN. CONFLICTING EXPLANT SURGERY DATE (B)(6) 2013 WAS PROVIDED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334485 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R