BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201639 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00481
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    February 9, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS NOT PROVIDING ANY RELIEF LIKE IT USED TO FOR THE PATIENT SINCE (B)(6) 2011. THERE WERE NO VOLUME DISCREPANCIES AT REFILLS AND ¿EVERYTHING SEEMED TO BE FUNCTIONING PROPERLY.¿ IT WAS SUSPECTED THAT THERE MIGHT BE A CATHETER DISPLACEMENT. THE PUMP WAS LAST REFILLED ON (B)(6) 2011. AT THAT TIME, THE PATIENT HAD TWO MONTHS UNTIL THE ELECTIVE REPLACEMENT INDICATOR (ERI) ALARM TRIGGERED AND APPROXIMATELY 90 DAYS AFTER ERI TO END OF SERVICE (EOS). THE PATIENT¿S PUMP WAS SCHEDULED TO ALARM ON (B)(6) 2012 FOR THE RESERVOIR VOLUME. ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT¿S PUMP HAD BEEN SOUNDING A CRITICAL ALARM FOR ¿A COUPLE OF WEEKS.¿ IT WAS ALSO REPORTED AT THAT TIME THAT MEDICATION WAS ¿NOT GETTING THROUGH THE CATHETER.¿ THE PATIENT¿S PUMP WAS REPORTED TO NOW BE EMPTY. THE PATIENT WAS GIVEN ORAL MEDICATION. THERE HAD BEEN ISSUES WITH SCHEDULING A PUMP REPLACEMENT. THE DRUG THE PUMP WAS DELIVERING WAS MORPHINE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPORTEDLY AT END OF LIFE (EOL)/END OF SERVICE (EOS). THE PATIENT STATED THAT THE PUMP ¿DIED¿ (B)(6) 2011 AND THE ALARM WAS GOING OFF. A REPRESENTATIVE REPORTEDLY HAD TO TURN OFF THE PUMP FOR HER. THE PATIENT COULD NOT FIND SOMEONE TO REPLACE THE PUMP YET. THE PATIENT HAD RELOCATED AND NEEDED TO ¿PROVE ALL OVER AGAIN¿ THAT SHE NEEDED THE PUMP. THE PATIENT ALSO MENTIONED SHE HAD ANEURYSM CLIPS IN HER BODY. THE PATIENT WAS TO HAVE A MAGNETIC RESONANCE IMAGING (MRI) SCAN OF HER SPINE BUT THIS WAS NOT RELATED TO THE PUMP. PLEASE NOTE THAT THE FOLLOWING INFORMATION HAD BEEN PREVIOUSLY REPORTED IN MANUFACTURER REPORT # 3007566237-2012-02309: THE PATIENT REPORTED A CHANGE IN THERAPY EFFECT. THE DRUG WAS NOT GETTING WHERE IT WAS SUPPOSED TO GO. THE PATIENT STATED THEY COULD NOT SEE ANY LEAKS FROM THE CATHETER. THE PUMP WAS FLIPPED AND SHE THOUGHT IT HAPPENED (B)(6). THE PUMP STUCK OUT. THE PATIENT WAS CURRENTLY ON ORAL MEDICATION FOR HER PAIN AND WAS NOT GETTING THE PUMP FILLED OR MANAGED BY ANYONE. THE PATIENT WAS LOOKING FOR A PHYSICIAN TO MANAGE THEIR CARE. THE PUMP WAS DELIVERING MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IT WAS LATER REPORTED THAT THE PUMP HAD BEEN OFF FOR A YEAR AND A HALF; THERE WAS NOTHING IN IT AND IT WAS NO LONGER WORKING. THE PATIENT REPORTED SHE USED TO HAVE MORPHINE AND BUPIVACAINE BUT THE PUMP WAS THEN DRY. THE PATIENT NOTED FINDING AN HCP THAT WOULD CHANGE THE PUMP; HOWEVER, SHE WAS ALSO LOOKING FOR AN HCP WHO WOULD MANAGE THE PUMP. THE PATIENT WAS EVALUATED AT HER FAMILY HCP CLINIC APPROXIMATELY 2 WEEKS AGO AND THE PATIENT NOTED TALKING TO A MANUFACTURER¿S REPRESENTATIVE THERE WHO WAS TRYING TO HELP HER FIND AN HCP TO MANAGE THE PUMP. THE PATIENT WAS REFERRED TO HER HCP. HOWEVER, ANY FURTHER INFORMATION PERTAINING TO THE NATURE OF THIS EVENT/ISSUES WILL NOW CONTINUE TO BE CAPTURED IN THIS MANUFACTURER REPORT #3007566237-2013-00481.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303406 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR