BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2113801 · Received May 17, 2011

    Report

    Report Number
    3004209178-2011-03584
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    December 1, 2010
    Report Date
    April 19, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL 8578, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), EXPLANTED: UNK.

    Description of Event or Problem · 1

    AN INFLAMMATORY MASS WAS REPORTED. THE PT'S INFLAMMATORY MASS WAS DETECTED BY AN MRI PERFORMED "BACK IN (B)(6) AND THEN AGAIN IN (B)(6)". THE PT HAD ACUTE PAIN OVER THE ENTIRE SYSTEM, AND ALSO A PINCHING SENSATION NEAR THE CATHETER PATHWAY. HEADACHE WAS FURTHER REPORTED. THE PT WAS HOME. NEITHER THE DRUG ADMINISTERED VIA THE PUMP, NOR THE PT'S OUTCOME WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT HCP HAD CARRIED OUT DIAGNOSTICS APPROX. SIX MONTHS POST IMPLANT AND PERFORMED CATHETER REVISION FOR CATHETER OCCLUSION CAUSED BY SUTURE. IT WAS STATED THAT PATIENT'S THERAPY GOT EVEN WORSE AFTER THE REVISION WITH SYMPTOMS OF HEADACHE, INCREASED BASELINE PAIN, LOSS OF BOWEL CONTROL, LOSS OF BLADDER CONTROL, DIFFICULTY WALKING, TINGLING IN LIMBS, WEIGHT LOSS, AND HEAVINESS IN LEGS, BEDRIDDEN FOR 1 YEAR. INCREASES IN PUMP DOSE WERE DONE BUT HAD NO EFFECT ON THE PAIN LEVEL. PATIENT DESIRED A CATHETER REPLACEMENT SINCE IT IS 10.5 YEARS OLD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE CATHETER OCCLUSION WAS NOTED TO HAVE OCCURRED ON 2011-(B)(6). PATIENT HAD EXPERIENCED THE SEVERE HEADACHES FOR APPROX. 4 MONTHS AND "THINKS SHE MAY HAVE A CSF (CEREBROSPINAL) LEAK". PATIENT DESIRED TO HAVE HER DEVICE AND CATHETER REMOVED AND FELT THAT SHE "WOULD BE BETTER WITH ORAL MEDS". PER ANOTHER REPORTER THERE HAD BEEN NO DEVICE TROUBLESHOOT. AS OF 2012-(B)(6), PATIENT WAS WORKING WITH HER HCP, AND IT WAS SATED THAT THE ISSUES WERE YET TO BE RESOLVED. DRUG DELIVERED VIA THE SYSTEM WAS DILAUDID.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT LATER REPORTED THAT HIS SPINAL FLUID HAD NEVER BEEN TESTED TO CHECK FOR INDICATORS OF GRANULOMA. THE PATIENT ALSO REPORTED THAT HE STILL BELIEVED HE HAS CATHETER ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R CATHETER: MODEL 8709, LOT# J10823R40| EXPLANTED:| IMPLANTED: