BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7907690 · Received September 25, 2018

    Report

    Report Number
    3004209178-2018-21511
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    September 23, 2018
    Report Date
    January 10, 2019
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID 8780, SERIAL# (B)(4), PRODUCT TYPE CATHETER. PRODUCT ID 8780, SERIAL# (B)(4), PRODUCT TYPE CATHETER, UDI# (B)(4). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: CATHETER. SECTION 'DEVICE' INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709, SERIAL/LOT #: (B)(4), UBD: 2015-02-01. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED, AND ANALYSIS FOUND GEAR TRAIN ANOMALY, CORROSION AND-OR WEAR AND-OR LUBRICATION AND STALL DUE TO SHAFT-BEARING. THE CATHETER WAS RETURNED AND ANALYSIS FOUND SC CONNECTOR/CORING-TEARS-CUTS IN SEAL. CATHETER BODY HAD DAMAGE TO THE TRANSITION TUBE. (B)(4) .IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN 500 MCG/ML; 170 MCG/DAY VIA AN IMPLANTABLE PUMP. INDICATION FOR USE WAS INTRACTABLE SPASTICITY AND CEREBRAL PALSY. THE DATE OF THE EVENT WAS (B)(6) 2018. IT WAS REPORTED THE PUMP STALLED AND RECOVERED ON (B)(6) 2018 THEN STALLED AGAIN ON (B)(6) 2018 WITH NO RECOVERY NOTED IN THE LOGS. THE PATIENT DID NOT RECENTLY HAVE MAGNETIC RESONANCE IMAGING (MRI). IT WAS CONFIRMED THERE WERE NO ELECTROMAGNETIC INTERFERENCE (EMI) OR MAGNETIC SOURCES WERE PRESENT. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER AND A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE. THE LOGS SHOW THAT THE PUMP MOTOR STALLED ON (B)(6) 2018 AT 4:20 AM AND RECOVERED AT 2:57 PM THE SAME DAY. THE PUMP CONTINUED TO ALARM THAT DAY SO THE PROVIDER SILENCED THE ACTIVE AUDIBLE ALARM. WHEN INTERROGATED ON 10/12/2018, HOWEVER, EARLY ELECTIVE REPLACEMENT INDICATOR (ERI) STATES 14 MONTHS AND THE PUMP HAD 34 ML OF BACLOFEN. THE PUMP WAS REPLACED ON (B)(6) 2018 DUE TO AN (ERI) ALARM. THE ISSUE WAS RESOLVED. PATIENT STATUS WAS ALIVE - NO INJURY. PATIENT WEIGHT AND MEDICAL HISTORY WERE ASKED BUT UNKNOWN. THE PUMP WAS DELIVERING GABLOFEN 500 MCG/ML;100 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749172 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention