BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3112199 · Received May 14, 2013

    Report

    Report Number
    3007566237-2013-01611
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, IMPLANTED: 2006-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8711, LOT# J11478R52, IMPLANTED: 2003-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THOUGHT THAT THE BATTERY WAS GOING OUT ON THE PUMP BECAUSE IT WAS BEEPING; IT WAS A SINGLE BEEP THAT THE PATIENT FELT SHE WAS HEARING ABOUT EVERY 6 HOURS. THE PATIENT HAD BEEN EXPERIENCING RETURN OF HER BASELINE PAIN AND WALKING FUNNY AGAIN SINCE THE PHYSICIAN REDUCED HER DOSE A FEW MONTHS PRIOR TO SEE IF SHE COULD BE WEANED OFF THE PUMP. IT WAS RECENTLY DETERMINED VIA X-RAY THAT THE CATHETER HAD BROKEN OFF AND A PIECE OF IT WAS FLOATING IN HER CEREBRAL SPINAL FLUID. THE PATIENT WAS WORKING WITH HER HEALTHCARE PROVIDER AND WAS BEING REFERRED TO A NEUROSURGEON TO GET THE PUMP REPLACED. THE PUMP WAS DELIVERING DILAUDID AND "THERE MIGHT BE CLONIDINE". THE NEXT DAY IT WAS REPORTED THAT THE PUMP HAD STARTED BEEPING IN THE LAST 3 DAYS. IT WAS BEEPING EVERY 2 HOURS; INITIALLY THE PATIENT THOUGHT IT WAS EVERY 6 HOURS. THE PATIENT VISITED THE CLINIC. THE PUMP WAS INTERROGATED AND THEY TOLD THE PATIENT THAT THE PUMP WASN'T ALARMING. THE PATIENT WAS TOLD THE "PUMP WAS IN BACKUP MODE" AND NEEDED TO BE REPLACED BY (B)(6). THE PHYSICIAN DISABLED THE ALARMS. THE CATHETER BREAK WAS FOUND DURING A PRE-OP X-RAY AS THE PUMP WAS SUPPOSED TO BE REPLACED, BUT WAS THEN CANCELED UNTIL THE PATIENT COULD SEE A NEUROSURGEON. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP WAS ¿BASICALLY NON-FUNCTIONING¿. THE PATIENT¿S MEDS HAD BEEN TURNED DOWN; THE LAST TURN DOWN OF MEDS WAS A WEEK AGO - (B)(6) 2013. THE PATIENT WAS WEANED OFF THE INTRATHECAL MEDS AND WAS ON NON-NARCOTIC ORAL MEDS. PER THE REPORTER, AS OF (B)(6) 2013 THE BATTERY WILL BE EXHAUSTED. AN MRI WAS THE NEXT STEP TO THE RESOLUTION PROCESS BECAUSE THE PATIENT WAS UNSURE IF SHE COULD GET THE PUMP REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212521 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention