BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2941529 · Received February 4, 2013

    Report

    Report Number
    3007566237-2013-00357
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# J11148R14, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP FOUND NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED CATHETER MIGRATION/DISLODGEMENT OCCURRED. THE PATIENT WAS REPORTED TO HAVE GONE THROUGH WITHDRAWAL "LAST WEEK - STARTED (B)(6)". THE PATIENT WAS SWEATING "REALLY BAD" AND INCREASED PAIN WAS REPORTED. THE PATIENT PRESENTED TO THE HOSPITAL AND WAS "WORKED UP MEDICALLY" AT WHICH TIME THEY FOUND HIS PUMP TO BE "DISCONNECTED". DURING THE REVISION, IT WAS REPORTED THE TREATING HEALTH CARE PROVIDER (HCP) FOUND THE CATHETER WAS OUT OF THE INTRATHECAL SPACE AND THE WHOLE CATHETER WAS REPLACED. THE PUMP WAS ALSO REPLACED AS IT WAS NEARING ITS ELECTIVE REPLACEMENT INDICATOR (ERI) AND HCP CHOSE TO REPLACE IT ALL AT ONCE. THE DEVICE SYSTEM WAS USED TO ADMINISTER INFUMORPH. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD ADDITIONAL SYMPTOMS OF NAUSEA, VOMITING AND DELIRIUM. THE CATHETER HAD A BREAK/TEAR/HOLE. ON (B)(6) 2013, AN X-RAY WAS DONE; THE RESULTS WERE NOT REPORTED. ON (B)(6) 2013, A DOSE ADJUSTMENT WAS DONE. THE PATIENT WAS HOSPITALIZED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46630 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R