BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3120298 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07894
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 7, 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
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REPORTED INFORMATION INDICATED THAT THE PATIENT HAD AN ¿URGENT OFFICE VISIT¿ ON (B)(6) 2013. THE PATIENT WAS GOING TO USE HER PTM AND IT DID NOT ALLOW HER TO DO SO AND TOLD HER TO SEEK MEDICAL ATTENTION. AT THIS TIME, THE PATIENT DID NOT HAVE ANY WITHDRAWAL SYMPTOMS BUT NOTICED AN INCREASE IN PAIN. THE PATIENT DENIED ANY BOWEL OR BLADDER CHANGES, ANY NEW NUMBNESS, TINGLING OR WEAKNESS IN THE LOWER EXTREMITIES. SHE DID NOT HAVE ANY EPISODES OF INCREASED SEDATION, NAUSEA, VOMITING OR EPISODES WHERE SHE FELT OVERMEDICATED. THE PUMP LOGS WERE REVIEWED AND SHOWED THAT THE PUMP DID NOT HAVE ANY RESERVE VOLUME, THAT THE PATIENT HAD ACTIVATED AND USED A SIGNIFICANT AMOUNT OF HER BOLUSES SINCE SHE WAS LAST SEEN FOR A REFILL. IT WAS REPORTED THAT IT SEEMED THAT THE PUMP WAS PROGRAMMED WITH THE CORRECT RESERVOIR VOLUME. HOWEVER, THE PTM SHOWED A SIGNIFICANT AMOUNT OF BOLUSES GIVEN, LOCKED OUT, AS WELL AS UNSUCCESSFUL ACTIVATIONS. THE PUMP WAS ACCESSED AND SHOWED TO HAVE THE APPROPRIATE AMOUNT OF MEDICATION THAT SHOULD BE PRESENT FOR A THREE-WEEK POST FILL. THE MEDICATION WAS PLACED BACK INTO THE PATIENT. THE PTM WAS DISABLED AND SENT BACK TO THE MANUFACTURER. A BOLUS WAS GIVEN TO THE PATIENT ON THE DAY OF THE OFFICE VISIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GETTING THE 8286 ERROR CODE (CRITICAL EMPTY RESERVOIR) LAST NIGHT. THE PUMP WAS LAST FILLED TWO WEEKS AGO AND THE NEXT PUMP REFILL DATE WAS SHOWING AS (B)(6) 2005. THE DEVICE SYSTEM WAS USED TO DELIVER CLONIDINE, BUPIVACAINE AND MORPHINE. IT WAS LATER REPORTED THAT THE LOW RESERVOIR ALARM WENT OFF AS WELL AS THE PTM ERROR CODE 8254 FOR THE LOW RESERVOIR. WHEN THE PUMP WAS INTERROGATED IT SHOWED THAT IT WAS EMPTY. WHEN THE HCP PULLED OUT THE DRUG IT WAS ALL THERE AND THE PATIENT WASN'T FEELING ANY WITHDRAWAL. FROM THE PRINTOUT, THE ACTIVATION HISTORY SHOWED 395 SUCCESSFUL ACTIVATIONS, 170 LOCKOUT ATTEMPTS AND 27 UNSUCCESSFUL ACTIVATIONS. "IN THE ALLOTTED TIME, THERE SHOULDN'T HAVE BEEN THAT MANY SUCCESSFUL ACTIVATIONS". THE PATIENT WAS THEN TAKEN OFF THE PTM ON (B)(6) 2013 AND WAS SEEN ON (B)(6) 2013 AND EVERYTHING SEEMED TO BE OK. THE PATIENT WAS GIVEN ANOTHER PTM FROM THE OFFICE. THE PATIENT STATUS WAS REPORTED AS ALIVE ¿ NO INJURY/NO ADVERSE EVENT. IT WAS LATER REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THE PHYSICIAN OR MEDTRONIC REPRESENTATIVE AND HER CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222182 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR