BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202680 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01148
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    May 14, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: CATHETER: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE A CATHETER BREAK AND/OR MIGRATION ON FOUR SEPARATE OCCASIONS (SEE MANUFACTURER¿S REPORT # 3007566237 -2012-01314, 3007566237-2013-01128, 3007566237-2013-01146 FOR PREVIOUSLY REPORTED EVENTS). IT WAS REPORTED THAT THE PATIENT HAS HAD ¿BAD WITHDRAWALS¿ 4 TIMES WITH THIS DEVICE AND IT DISRUPTED HER LIFE. IT WAS REPORTED THAT THE PATIENT¿S CURRENTLY IMPLANTED CATHETER WAS NOT IN GOOD WORKING CONDITION; IT WAS REPORTED THAT IT KEPT BREAKING. IT WAS REPORTED THAT THE PATIENT¿S BACK WAS FUSED. THE PATIENT DID NOT THINK SHE HAD FALLEN ¿SINCE THE DEVICE HAS BEEN IN¿. IT WAS REPORTED THAT THE PHYSICIAN DOES NOT KNOW WHY THE CATHETERS KEPT BREAKING. IT WAS REPORTED THAT EACH TIME THEY TRIED TO ¿SECURE IT BETTER¿. IT WAS REPORTED THAT ¿IT WAS LIKE EVERY YEAR IT WAS BREAKING OR NOT BREAKING IN THE SAME AREA OR PULLING OUT¿, SO THE HEALTH CARE PROVIDER (HCP) WANTED TO REFER THE PATIENT TO "SOMEBODY WHO MIGHT BE ABLE TO PUT THIS IN DIFFERENTLY". IT WAS REPORTED THAT THE DEVICE WORKED GREAT FOR A YEAR FOLLOWING REVISION AND THEN THE PATIENT GOT ¿REALLY SICK¿ AND AN X-RAY OR TEST PUMP INDICATED THAT IT WAS ¿NOT EVEN RUNNING." ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012, INDICATED THAT THE PATIENT¿S PUMP ALARM WAS GOING OFF. A NON-CRITICAL ALARM HAD BEEN SHUT OFF PREVIOUSLY, APPROXIMATELY TWO MONTHS AGO, BUT A CRITICAL ALARM WAS GOING OFF AT THE TIME OF THIS SECONDARY REPORT AND HAD BEEN GOING OFF FOR ¿A COUPLE OF DAYS¿. THE PUMP HAD BEEN SET ON A VERY LOW RATE WITH THE INTENTION OF IT RUNNING FOR ¿MAYBE A YEAR OR MORE OR SOMETHING¿ UNTIL A DECISION WAS MADE TO REPAIR THE SYSTEM AGAIN OR NOT. IT WAS REPORTED THAT THE LAST TIME THE CATHETER BROKE, THE FOURTH TIME, WAS ABOUT SEVEN OR EIGHT MONTHS AGO. 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
    302826 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Hospitalization| R