BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3843882 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09981
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    November 7, 2013
    Report Date
    May 13, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE IMPLANT, THE PATIENT HAD BEEN HAVING TROUBLE WITH PAIN CONTROL. THE PATIENT WENT IN FOR A STIMULATION TRIAL ON (B)(6) 2014. WHEN THE TRIAL STIMULATOR WAS PLACED, THAT PATIENT FELT THE PUMP CONTRACT. THE PATIENT ASKED THAT THE STIMULATOR BE TURNED OFF. IT WAS MOVED OVER AND THEN IT WAS FINE AFTER THAT. WHEN THE PATIENT WENT IN ON (B)(6) 2014 TO HAVE IT TAKEN OUT, SHE WAS TOLD THAT HER PUMP WAS FLIPPED. THE DOCTOR TRIED TO FLIP THE PUMP BACK OVER ON (B)(6) 2014, BUT IT WOULDN¿T GO AND IT SCARED THE PATIENT. ON (B)(6) 2014, THE HCP (HEALTH CARE PROVIDER) TURNED THE PUMP SIDEWAYS AND REFILLED IT. THE PATIENT HAD BEEN IN TERRIBLE PAIN SINCE; HER USUAL PAIN WAS WORSE THAN IT WAS BEFORE THEY TRIED THE STIMULATOR FOR HER LEFT FOOT AND LEFT LEG. THE PATIENT HAD RETURN OF SYMPTOMS/INCREASED BASELINE PAIN AND A HEADACHE. THE PATIENT HAD AN APPOINTMENT (B)(6) 2014 FOR ADDITIONAL FOLLOW-UP REGARDING HER CURRENT SYMPTOMS AND PAIN. IT WAS ALSO REPORTED THAT THE PATIENT HAD FLUID ON TOP OF THE PUMP; IT HAD BEEN DRAINED FOUR TIMES. THE PATIENT HAD ALSO GAINED BODY MASS. THE HCP TOLD THE PATIENT THAT THEY WERE GOING TO GO IN AND PUT IN SOME MESH AND THEY DIDN¿T KNOW IF THE CATHETER WAS CONNECTED BECAUSE THE PATIENT HAD BEEN HURTING SO BAD. THE PATIENT WAS PUT IN AN X-RAY AND THE HCP COULDN¿T TELL THE CATHETER POSITION. THE PATIENT STATED THAT SHE WAS SCARED AND DIDN¿T KNOW WHAT WAS GOING ON. THE DEVICE SYSTEM WAS DELIVERING DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP DID FLIP OVER AND THE HEALTHCARE PROVIDER ATTEMPTED TO ¿RIGHT¿ THE PUMP; HOWEVER, THE PUMP REQUIRED SURGERY TO CORRECT THE POSITION. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT HAVING ANY SYMPTOMS. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. IT WAS LATER REPORTED THAT THE HEALTHCARE PROVIDER ATTEMPTED TO ¿RIGHT¿ THE PUMP UNDER ANESTHESIA. THE CATHETER WAS CONNECTED TO THE PUMP. THE PATIENT HAD A SIGNIFICANT POST-OP SEROMA FORMATION THAT LEAD TO THE PUMP FLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321414 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention