BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1872522 · Received October 12, 2010

    Report

    Report Number
    3007566237-2010-07826
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RENAL KIDNEY CYST.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, PT FELT A HARD SPOT/LUMP OVER HER BACK WHERE THE CATHETER WAS PLACED. THE PT INDICATED THAT THIS WAS CAUSING HER PAIN SIMILAR TO HAVING A CRACKED RIB. THE PT THOUGHT, SHE HAD AN INFLAMMATORY MASS. THE PT STATED, SHE NEVER HAD THERAPEUTIC EFFECT. IT WAS NOTED, THE PT WAS CONSIDERING TAKING THE PUMP OUT AND WAS IN THE PROCESS OF TITRATING OFF THE MEDICATION. THE PT INDICATED THAT SHE WAS NOT GETTING THE RELIEF THAT SHE EXPECTED. THE, SHE HAD A RENAL KIDNEY CYST BUT THAT SHE SHOULD NOT BE IN SO MUCH PAIN FROM THE CYST. THE PT WAS REFERRED TO ANOTHER DR TO DO AN X-RAY OR MAGNETIC RESONANCE IMAGING (MRI) OF THE CATHETER TIP LOCATION. THE PUMP CONTAINED MORPHINE. AT THE TIME OF THIS REPORT, NO FURTHER INFO WAS REPORTED. ADD'L INFO WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    ON 2015-12-17, ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER, REGARDING A PATIENT WHO WAS RECEIVING MORPHINE (LOT NUMBER, CONCENTRATION, DOSE, AND DATES OF THERAPY UNKNOWN) VIA AN IMPLANTABLE PUMP. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2005, AND FOR THE FIRST TWO DAYS IN THE HOSPITAL FOLLOWING PUMP IMPLANT, IT WAS REVEALED THAT THE CATHETER DID NOT GO IN RIGHT AND THEY HAD TO RE-DO IT; THE CATHETER WAS REVISED. THE PATIENT ALSO STATED THAT THEY NEVER GOT GOOD PAIN RELIEF FROM THE PUMP SINCE THE DATE OF IMPLANT. ON AN UNKNOWN DATE IN 2009, A MAGNETIC RESONANCE IMAGING (MRI) SHOWED A MASS AT THE TIP OF THE CATHETER, AND THE CATHETER WAS "LOOSENED UP AND LEAKING." SUBSEQUENTLY, ON AN UNSPECIFIED DATE IN 2009, THE PUMP WAS REMOVED. THE PATIENT STATED THAT, ACCORDING TO THE HEALTHCARE PROVIDERS (HCP) NOTES, THAT THE PUMP AND CATHETER WERE REMOVED. SUBSEQUENTLY, ON AN UNSPECIFIED DATE, THE PATIENT HAD ANOTHER MRI BECAUSE THEY WERE DEALING WITH BACK PROBLEMS AND PAIN SINCE THE PUMP WAS REMOVED IN 2009; THE PATIENT WAS TOLD THAT THE CATHETER WAS WRAPPED AROUND THE SPINE AND TISSUES. ON AN UNSPECIFIED DATE IN 2010, THE PATIENT HAD SCAR TISSUE BUILD UP, OR MAYBE A HERNIA; THIS WAS ALSO DESCRIBE AS A "DIP" WHERE THE PUMP WAS PLACED AND SUBSEQUENTLY REMOVED. AS OF (B)(6) 2015, THE SITUATION WAS BEING ADDRESSED BY THE HCP, AND REDIRECTION OF THE PATIENT TO THEIR HCP TO WORK ON THEIR ISSUES WAS RECOMMENDED. ADDITIONAL INFORMATION REGARDING THE PUMP DRUG DETAILS, DATE OF PUMP AND CATHETER REMOVAL, CLARIFICATION OF COMPLETE VERSUS PARTIAL CATHETER REMOVAL, CLARIFICATION OF CATHETER "LOOSENED UP" STATEMENT, CONFIRMATION AND INTERVENTIONS RELATED TO THE HERNIA, RESOLUTION OF THE MASS AT THE CATHETER TIP, RELATIONSHIP OF BACK PROBLEMS TO CATHETER WRAPPED AROUND THE SPINE AND TISSUES, AND RESOLUTION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention EXPLANTED:| IMPLANTED: