BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3172689 · Received June 17, 2013

    Report

    Report Number
    3007566237-2013-01994
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8703, LOT# J94142210, IMPLANTED: (B)(6) 1994. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME INTO THE HOSPITAL 72 HOURS PRIOR BECAUSE HE ASPIRATED AND HAD A MECHANICAL BOWEL OBSTRUCTION; THE PATIENT WAS NOT A SURGICAL CANDIDATE. DURING A SPIRAL CT SCAN OF THE ABDOMEN, THE RADIOLOGIST NOTICED WHAT LOOKED LIKE DISCONTINUITY OF THE CATHETER. THEY QUESTIONED WHETHER THE CATHETER WAS FRACTURED SOMEWHERE IN THE MIDDLE; THEY WERE DOING A CATHETER DYE STUDY (B)(6) 2013 TO FURTHER INVESTIGATE. THE PATIENT HAD SEVERE SPASTICITY AND WAS VERY DEMENTED; HE WAS A NON-MOBILE PATIENT. IT WAS INITIALLY THOUGHT THAT THE BOWEL OBSTRUCTION WAS CAUSING THE SPASTICITY, BUT THAT WAS CLEARED UP. NOW, THE PATIENT¿S LEGS HAD BECOME MUCH LOOSER. THE PATIENT WAS STARTED ON ORAL BACLOFEN. THE PUMP WAS DELIVERING GABLOFEN. IT WAS LATER REPORTED THAT THE CT SCAN WAS DONE ON (B)(6) 2013. DURING THE CATHETER DYE STUDY ON (B)(6) 2013, DYE LEAKED AT THE FRACTURE SITE THAT WAS ABOUT MIDWAY ALONG THE CATHETER. THE CATHETER BREAK WAS ABOUT 4 INCHES BEFORE THE DISTAL POINT OF ENTRY INTO THE SPINE AND ABOUT 3-4 INCHES FROM WHERE THE CATHETER CURVED AND WENT TOWARD THE FLANK; THE BREAK WAS NOT AT THE PUMP END OR SPINAL SEGMENT. AFTER THE CATHETER FRACTURE WAS CONFIRMED, THE FAMILY DECIDED TO HOLD OFF ON DOING ANYTHING BECAUSE THE PATIENT WAS GOING TO NEED A PUMP AND CATHETER REPLACEMENT AND THE PATIENT WAS STABLE ON THE ORAL BACLOFEN. THE PATIENT HAD ADVANCED DEMENTIA OF ALZHEIMER¿S TYPE AND HEREDITARY SPASTIC PARAPARESIS WITH LEGS NOW PLEGIC.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE FAMILY DECIDED AGAINST PUMP OR CATHETER REPLACEMENT BECAUSE OF THE PATIENT¿S ADVANCED DEMENTIA AND THE ORAL BACLOFEN WAS WORKING TO CONTROL HIS SPASTICITY. THE BOWEL IMPACTION WAS NOT RELATED TO THE DEVICES. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273488 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization