BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3191281 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10925
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 31, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER: PRODUCT ID 8840, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THERE WAS NO ISSUE WITH THE PHYSICIAN PROGRAMMER. THE PATIENT HAD A MASSIVE FLUID ACCUMULATION OVER THE PUMP WHICH PREVENTED INTERROGATION. AS SOON AS THE FLUID WAS DRAINED, THE PUMP WAS ABLE TO BE INTERROGATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTHCARE PROVIDER (HCP) WAS NOT ABLE TO DO TELEMETRY OR COMMUNICATE WITH THE PATIENT¿S PUMP AT THE LAST REFILL IN APRIL. THE PATIENT WAS AT THE HOSPITAL ON THE DAY OF REPORT FOR A REVISION/EXPLORATORY SURGERY TO DETERMINE THE CAUSE. THE PATIENT HAD BEEN REALLY SICK, BED RIDDEN AND HAD BEEN "SQUIRMING" IN BED DUE TO BEING SO UNCOMFORTABLE. THE PATIENT¿S PUMP POCKET SITE WAS SWOLLEN AND THERE WAS A LOT OF FLUID ACCUMULATION AT THE PUMP SITE. THE REPORTER INDICATED THAT IT WAS POSSIBLE THE PUMP COULD BE FLIPPED. THERE WAS NO ALARM ASSOCIATED WITH THEM NOT BEING ABLE TO COMMUNICATE WITH THE PUMP AND 8840. IT WAS LATER REPORTED THAT SAME DAY THAT THE PATIENT HAD A MASSIVE FLUID SAC SURROUNDING THE PUMP, AND THE HCP DRAINED 900ML'S OF CEREBROSPINAL FLUID (CSF). THE PUMP WAS ALSO FOUND TO BE FLIPPED MULTIPLE TIMES AND THE CATHETER WAS ALL TWISTED UP. THE HCP REPLACED THE PUMP SEGMENT OF THE CATHETER AND DETERMINED THE EXISTING PUMP WAS STILL FUNCTIONING. THE PUMP WAS USED TO DELIVER MORPHINE AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE PUMP WAS NOT REPLACED, AS THEY ONLY REPLACED THE PROXIMAL PORTION OF THE CATHETER. THE PATIENT HAD ADMITTED TO FLIPPING THE PUMP THEMSELVES. 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
    291498 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention