BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2260068 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06907
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0592-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED THAT THE PT EXPERIENCED A 30 POUND WEIGHT GAIN IN THE LAST MONTH AND HAD AT LEAST 4 FALLS. TWO OF THOSE FALLS WERE FACE-FORWARD, WHICH LEAD TO BRUISING ON HER CHEST. THE PT WAS NOT SURE IF THE PUMP WAS HIT DURING THE FORWARD FALLS, ONE OF WHICH WAS DOWN A 3-STEP FLIGHT OF STAIRS. DURING A PUMP REFILL THAT OCCURRED THE FIRST WEEK OF (B)(6) 2011, THE PUMP HAD A LARGE VOLUME DISCREPANCY (ACTUAL AMOUNT WAS GREATER THAN EXPECTED). AT THAT TIME, THE PT HAD NO SIGNS/SYMPTOMS OF WITHDRAWAL; HOWEVER ON (B)(6) 2011, THE PT EXPERIENCED INCREASED PAIN AND INCREASED SPASMS. ON (B)(6) 2011, A DYE AND ROTOR STUDY WERE PERFORMED. CSF WAS WITHDRAWN, BUT THE PT HAD A PSEUDOMENINGOCELE, "SO IT MIGHT BE FLUID WHICH ACCUMULATED AT THAT SITE." DURING THE DYE STUDY, THE DYE DID NOT LEAK AND NO FRACTURE WAS SEEN. THE RADIOLOGIST SAW DYE EXIT FROM THE TIP OF THE CATHETER WHICH WAS LOCATED AT L1 (LOWER THAN IMPLANT LEVEL), BUT THE REPORTER DID NOT. THE ROTOR STUDY REVEALED THE MOTOR MOVED COUNTER-CLOCKWISE. THE PLAN WAS TO REFER THE PT TO A SURGEON FOR A REVISION SURGERY. IT WAS LATER REPORTED THAT AN MRI WAS COMPLETED ON (B)(6), AND A MOTOR STALL RECOVERED 35 MINS LATER. PUMP EVENT LOGS WERE OTHERWISE INDICATED AS BEING NORMAL. THE DRUGS INFUSED WERE BACLOFEN 310MCG/ML AT DAILY DOSE OF 87.57 MCG AND DILAUDID 100 MCG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention CATHETER: MODEL 8709, LOT# N084798032| CATHETER: MODEL 8709SC, LOT# N123616008| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT # N084798032| IMPLANTED:| CATHETER: MODEL 8709SC, LOT # N123616008| EXPLANTED:| IMPLANTED: