BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202850 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11233
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 11, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FOLLOWING IMPLANT, THE PATIENT¿S PAIN WAS UNREMITTING AND SEVERE, SUCH THAT SHE HAD TO BE READMITTED ON (B)(6). AT THAT TIME, THE PATIENT WAS PLACED ON INTRAVENOUS PCA (PATIENT-CONTROLLED ANALGESIA) WITH ESCALATING DOSES AND ENDED UP IN HOSPICE. THE REPORTER STATED THAT THE PAIN DIDN¿T MEAN THAT THERE WAS A PROBLEM WITH THE PUMP, BUT THAT THE PATIENT MIGHT NOT HAVE BEEN TITRATED. AT THE TIME OF REPORT, THE PATIENT WAS ALSO HAVING SPASMS OF HER LOWER EXTREMITIES THAT LOOKED LIKE ¿MUSCULAR STIMULATION FROM AN ELECTRICAL CHARGE¿. THE REPORTER COMPARED IT TO THE EFFECT THAT A PACEMAKER HAD ON MUSCLE. IT WAS STATED THAT IT WOULD SET OFF A ¿WRACKING, SEVERE PAIN¿, THAT WAS SO BAD, THAT THE PATIENT HAD BEEN SEDATED. IT WAS ALSO NOTED THAT THE DEVICE WAS IN HER LEFT THIGH. THE PHYSICIAN WANTED TO TURN THE PUMP OFF BECAUSE HE THOUGHT THERE WERE SOME PROBLEMS WITH IT. HE WAS WORRIED THAT THERE WAS AN ELECTRICAL LEAK FROM THE DEVICE THAT WAS CAUSING THE MUSCLES TO FIRE. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301236 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization