BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3092377 · Received May 3, 2013

    Report

    Report Number
    3007566237-2013-01522
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) HAD BEEN TRYING TO SCHEDULE THE EXPLANT OF THIS PUMP AS IT WAS EXPECTED TO BE NEARING END OF LIFE. HOWEVER, BEFORE THAT WAS ABLE TO BE SCHEDULED, THE PUMP HAD ALARMED. UPON INTERROGATION, IT WAS NOTED THAT THE PUMP HAD STALLED AND THE PUMP REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI). THE PUMP LOGS WERE REVIEWED WHICH INDICATED THE PUMPED HAD BEEN INTERMITTENTLY STALLING SINCE (B)(6) 2013. THE LAST STALL WAS ON (B)(6) 2013 AND THE PUMP HAD NOT RECOVERED AS OF THE DATE OF THIS REPORT. IN ADDITION, THE PUMP HAD REACH ERI ON (B)(6) 2013. THE PATIENT DID NOT HAVE ANY SYMPTOMS AND WAS ALSO ON ORAL BACLOFEN. THE PATIENT HAD A PRE-OP CONSULTATION ALREADY SCHEDULED WITH THE SURGEON ON (B)(6) 2013 OF WHICH REPLACEMENT WOULD THEN BE SCHEDULED AFTER. IT WAS NOTED THAT THE SURGERY WOULD HAVE TO BE MOVED UP. AT THIS TIME THE PHYSICIAN HAD ELECTED TO REPROGRAM THE PUMP TO MINIMUM RATE MODE. THIS DEVICE SYSTEM DELIVERED BACLOFEN. 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
    195279 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention