BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5166417 · Received October 21, 2015

    Report

    Report Number
    3004209178-2015-21166
    Event Type
    Injury
    Date Received
    October 21, 2015
    Date of Event
    September 29, 2015
    Report Date
    September 29, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IDENTIFIED A GEAR TRAIN ANOMALY WITH CORROSION, WHICH RESULTED IN A PUMP MOTOR STALL DUE TO SHAFT BEARING.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE UPDATED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, 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

    ON 2015-09-29, INFORMATION WAS RECEIVED FROM A CONSUMER AND A COMPANY REPRESENTATIVE REGARDING A (B)(6) YEAR-OLD, MALE PATIENT WHO WAS RECEIVING FENTANYL AND AN UNKNOWN DRUG (DOSES AND CONCENTRATIONS UNKNOWN) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND RADICULAR PAIN SYNDROME. THE PATIENT'S MEDICAL HISTORY INCLUDED DIABETES (SINCE 2000). ON (B)(6) 2015, SINCE 1:30AM, THE PATIENT HAD SEEN CODE 8476 ON THEIR PERSONAL THERAPY MANAGER (PTM) WHICH INDICATED A MOTOR STALL HAD OCCURRED. THE PATIENT DID NOT HEAR THE PUMP ALARM. HE HAD NOT RECENTLY HAD A MRI AND WAS NOT EXPOSED TO ANY STRONG ELECTROMAGNETIC SOURCES. THE PATIENT EXPERIENCED PAIN, SHAKINESS IN HIS LEGS (LIKE RESTLESS LEG SYNDROME), HIGH BLOOD SUGAR AND EXTREMELY BRITTLE. THE PATIENT WAS TO FOLLOW-UP WITH THEIR HEALTHCARE PROVIDER (HCP). ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DRUG INFORMATION, THE PATIENT'S MEDICAL HISTORY AND CONCOM ITANT MEDICATIONS, TROUBLESHOOTING, ACTIONS/INTERVENTIONS AND THE CAUSE OF THE EVENT, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON 2015-10-23, ADDITIONAL INFORMATION WAS RECEIVED AND THE PUMP WAS RETURNED. THE PATIENT WAS RECEIVING FENTANYL 2500MCG/ML AT 121.1 MCG/DAY, CLONIDINE 625.0 MCG/ML AT 30.28 MCG/DAY, AND BUPIVACAINE 2.5 MG/ML AT 0.1211 MG/DAY VIA THE IMPLANTABLE PUMP. ON (B)(6) 2015 AT 10:11, A STOPPED PUMP PERIOD MAY EXCEED TUBE SET OCCURRED. ON (B)(6) 2015 AT 11:55 THE MOTOR STALL RECOVERED. ON (B)(6) 2015 AT 04:28, ANOTHER MOTOR STALL OCCURRED FOLLOWED BY A STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON (B)(6) 2015 AT 04:28. ON (B)(6) 2015 AT 00:10, THE STALL RECOVERED.

    Description of Event or Problem · 1

    ON (B)(4) 2015, INFORMATION WAS RECEIVED FROM A CONSUMER AND A COMPANY REPRESENTATIVE REGARDING A (B)(6) MALE PATIENT WHO WAS RECEIVING FENTANYL AND AN UNKNOWN DRUG (DOSES AND CONCENTRATIONS UNKNOWN) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND RADICULAR PAIN SYNDROME. THE PATIENT'S MEDICAL HISTORY INCLUDED DIABETES (SINCE 2000). ON (B)(6) 2015, SINCE 1:30AM, THE PATIENT HAD SEEN CODE 8476 ON THEIR PERSONAL THERAPY MANAGER (PTM) WHICH INDICATED A MOTOR STALL HAD OCCURRED. THE PATIENT DID NOT HEAR THE PUMP ALARM. HE HAD NOT RECENTLY HAD A MRI AND WAS NOT EXPOSED TO ANY STRONG ELECTROMAGNETIC SOURCES. THE PATIENT EXPERIENCED PAIN, SHAKINESS IN HIS LEGS (LIKE RESTLESS LEG SYNDROME), HIGH BLOOD SUGAR AND ¿EXTREMELY BRITTLE.¿ THE PATIENT WAS TO FOLLOW-UP WITH THEIR HEALTHCARE PROVIDER (HCP). ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DRUG INFORMATION, THE PATIENT¿S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS, TROUBLESHOOTING, ACTIONS/INTERVENTIONS AND THE CAUSE OF THE EVENT, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696433 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention