BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3024134 · Received March 27, 2013

    Report

    Report Number
    3007566237-2013-00908
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 8709, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER; PRODUCT ID: 8709, LOT#: J0039907R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT END OF LIFE (EOL)/END OF SERVICE (EOS) HAD OCCURRED AND IT WAS SUSPECTED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) HAD BEEN MISSED. THE PHYSICIAN HAD SCHEDULED A PUMP REPLACEMENT FOR (B)(6) 2013. THEN THE PATIENT WAS HOSPITALIZED DUE TO WITHDRAWAL, INCREASED PAIN, NAUSEA AND VOMITING, AND REFLEX TACHYCARDIA. INTERROGATION OF THE PUMP CONFIRMED EOS OCCURRED ON (B)(6) 2013 AND ERI WAS THOUGHT TO HAVE OCCURRED ON (B)(6) 2012. IT WAS STATED THE PHYSICIAN BELIEVED THE TACHYCARDIA WAS DUE TO CLONIDINE CESSATION. THE PUMP WAS BEING USED TO DELIVER CLONIDINE, MARCAINE AND MORPHINE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE BATTERY DEPLETION WAS CONSIDERED TO BE NORMAL, ACCURATE, AND EOL WAS EXACT. THE PATIENT WAS NOTED TO BE DOING BETTER; AND THE PUMP WAS REPLACED.

    Description of Event or Problem · 1

    FURTHER INFORMATION REPORTED THE BATTERY DEPLETION WAS "NORMAL" AND THE END OF LIFE WAS "ACCURATE." THE PUMP WAS REPLACED. ON THE DATE OF THIS FOLLOW UP REPORT, THE PATIENT WAS DOING "BETTER." IT WAS ALSO NOTED THAT THE DOSE OF MARCAINE BEING DELIVERED WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125695 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R