BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3061581 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06358
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 18, 2013
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HCP STATED THAT THE REASON HE CHANGED THE CATHETER WAS BECAUSE HE WAS REPLACING THE PUMP AND HE WANTED TO START OVER WITH A BRAND NEW SYSTEM. THE HCP STATED THERE WERE NO DIAGNOSTICS PERFORMED ON THE CATHETER. THE WHOLE CATHETER WAS REPLACED AND THEY DID NOT SAVE THE CATHETER, IT WAS DISCARDED. THE HCP NOTED THE ONLY SYMPTOM THE PATIENT HAD WAS INADEQUATE PAIN RELIEF. THE HCP ALSO SPECULATED THAT POSSIBLY THE ANCHOR WAS PLACED TOO TIGHTLY AND COULD HAVE BEEN INTERMITTENTLY DISRUPTING THERAPY. IT WAS UNCLEAR WHETHER THE CATHETER WAS REVISED PRIOR TO BEING REPLACED DURING THE PUMP REPLACEMENT. THE HCP ALSO STATED THAT AT SOME POINT, THE PATIENT HAD WITHDRAWAL SYMPTOMS AND PAIN. THE CATHETER AND PUMP REPLACEMENT HAPPENED ON THE SAME DAY. PLEASE REFER TO MANUFACTURER REPORT # 3004209178-2013-06361 FOR MOTOR STALL-NO RECOVERY/PUMP REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A CATHETER REVISION. THE PATIENT STAYED OVERNIGHT IN THE HOSPITAL AND WAS DISCHARGED THE FOLLOWING DAY. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. IT WAS NOTED, THE PUMP SYSTEM WAS BEING USED TO DELIVER BUPIVACAINE AND MORPHINE. IT WAS ADDITIONALLY REPORTED THAT THE DRUG IN THE PUMP WAS INFUMORPH. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162278 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R