BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2914858 · Received January 15, 2013

    Report

    Report Number
    3004209178-2013-00582
    Event Type
    Injury
    Date Received
    January 15, 2013
    Report Date
    December 19, 2012
    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
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8 709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER: PRODUCT ID 8551, LOT# 61148998, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONALLY IT WAS REPORTED THAT THE HEALTHCARE PROVIDER COULD NOT FIND PORT TO REFILL AND FLIPPED THE PUMP BACK OVER UNDER FLUORO; PER REPORTER THE PUMP WAS IMPLANTED CORRECTLY BUT JUST FLIPS". PATIENT HAD NO SYMPTOMS AT THE TIME. HCP ASPIRATED CATHETER TO CHECK PATENCY AND REFILLED THE PUMP. PATIENT WAS REFERRED FOR SURGICAL CONSULT TO SECURE PUMP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PUMP LOCATION IS CURRENTLY AWKWARD AND HEALTHCARE PROVIDER (HCP) PLANNED TO REVISE AND REPOSITION SO IT FEELS BETTER FOR PATIENT. IT WAS STATED THAT THE PUMP FLIPPED ONCE ALREADY LAST (B)(6) 2012 ((B)(6)) AND IT WAS MANUALLY FLIPPED AND IT HURT; PATIENT DIDN¿T WANT TO DO IT AGAIN. AT THE TIME THEY DECIDED TO MANUAL FLIP IT BECAUSE PATIENT HAD A LOT TO DO FOR (B)(6) WITH HER TWO KIDS AND VERY EMOTIONAL TIME. PATIENT HAD NO ISSUES SINCE. IT WAS ALSO STATED THAT ONE TIME THEY THOUGHT IT HAD FLIPPED SINCE (B)(6) 2012 AND THEY DID A X-RAY FLUORO AND CONFIRMED IT HAD NOT FLIPPED.

    Description of Event or Problem · 1

    WHEN TRYING TO REFILL THE PUMP, THE HEALTHCARE PROVIDER (HCP) WAS HAVING DIFFICULTY ACCESSING THE CENTER PORT. IT WAS DETERMINED, VIA LATERAL X-RAY, THAT THE PUMP WAS FLIPPED. THE PATIENT HAD SOME PAIN AT THE PUMP SITE RECENTLY; NO OTHER SYMPTOMS WERE REPORTED. THE DEVICE SYSTEM WAS DELIVERING BUPIVACAINE AND MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: AS OF THIS DATE PATIENT WAS UNDERGOING IMAGING TO CONFIRM IF THE PUMP HAD FLIPPED. IT WAS STATED THAT THE PATIENT WAS IN FOR A REFILL TODAY AND THAT IS WHEN THEY STARTED TO THINK THE PUMP WAS FLIPPED. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23029 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention