BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2840830 · Received November 20, 2012

    Report

    Report Number
    3004209178-2012-10590
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-28, LOT# V193909, IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3093-28, LOT# V032633, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS "BARELY GOING TO THE BATHROOM," AND SHE WAS UNSURE IF HER STIMULATOR'S SETTINGS WERE 'MESSED UP'. THE STIMULATOR HAD BEEN TURNED OFF FOR A COLOSTOMY BAG REPLACEMENT SURGERY (WHICH HAD TAKEN PLACE MID-OCTOBER) BUT WAS NOW TURNED ON. STIMULATION HAD BEEN INCREASED ON BOTH SIDES ON (B)(6) 2012, BUT THERE WAS "NO CHANGE". THE PATIENT COULD NOT REMEMBER IF THEIR THERAPY WAS BETTER PRIOR TO THE SURGERY. THE PATIENT'S HEALTH CARE PROVIDER (HCP) STATED THAT THE PATIENT'S BLADDER WAS PUSHED UP IN THE DIAPHRAGM, AND THE HCP HAD TO EMPTY IT DURING THE SURGERY. THE PATIENT HAD NOT BEEN ABLE TO URINATE FOR PERIODS OF 12-14 HOURS SOMETIMES UP TO 16 HOURS WHICH STARTED ABOUT A WEEK AGO. IT WAS NOT CLEAR IF THIS CONDITION AROSE BEFORE OR AFTER THE NEW COLOSTOMY BAG WAS PUT IN. THE BOWEL AND RECTUM WERE REPORTED TO BE ALL TIED TOGETHER AND CAUSING PAIN. THE HCP INDICATED THAT THIS COULD RELATE TO THE PATIENT'S PAIN. THE PATIENT HAD BEEN IN THE HOSPITAL SEVERAL TIMES OVER THE PAST 3 MONTHS, THOUGH IT WAS UNCLEAR IF THE DEVICE HAD CONTRIBUTED TO THE PATIENT'S HOSPITALIZATION(S) AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Description of Event or Problem · 1

    FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS LAST SEEN (B)(6) 2012 AND THE PATIENT WAS DOING "WELL." THE PATIENT HAD HAD BOWEL SURGICAL INTERVENTION FOR SCLEROSING MESENTERITIS IN (B)(6) OF 2012. IMPEDANCES WERE NORMAL ON LAST CHECK IN (B)(6). IT WAS UNKNOWN IF HOSPITALIZATION WAS REQUIRED. IT WAS NOTED THE PATIENT HAD CHRONIC CONDITION OF SCLEROSING MESENTERITIS WHICH THEY HAD HAD MULTIPLE BOWELS SURGERIES. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1