BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2163387 · Received June 28, 2011

    Report

    Report Number
    3004209178-2011-04862
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    April 27, 2011
    Report Date
    June 2, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS ARE PENDING FOR THE CATHETER ONLY. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED INTERMITTENT ITCHING AND AN ERRATIC PATTERN OF CLONUS AND TONE. THE SYMPTOMS WOULD LAST FOR "2 DAYS TO 2 WEEKS", AND THEN THE PT WOULD BE SYMPTOM-FREE FOR DAYS OR WEEKS. THE PUMP WAS USED WITH LIORESAL. THE PT WAS TREATED WITH ORAL BACLOFEN FOR SYMPTOMS OF WITHDRAWAL ON AN AS-NEEDED BASIS. THE PUMP DOSE WAS ADJUSTED SEVERAL TIMES FROM (B)(6) TO (B)(6) 2011. A (B)(4) STUDY COULD NOT BE PERFORMED DUE TO "POOR FLOW". THE PT UNDERWENT REVISION SURGERY ON (B)(6) 2011. DURING SURGERY, IT WAS DISCOVERED THE PUMP HAD ROTATED AND THE CATHETER HAD KINKED AT THE PROXIMAL (PUMP) SEGMENT. DURING THE SURGERY, THE DACRON POUCH WAS FOUND TO BE "SCARRED IN," BUT THE PUMP WAS NOT WITHIN THE POUCH. THE CATHETER WAS DISSECTED IN THE DORSAL INCISION BY THE PHYSICIANS. THE CATHETER WAS FOUND AND ITS ENTIRETY IN THE PARASPINOUS MUSCLES. THE OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention CATHETER: MODEL 8709, LOT# J11686R48| EXPLANTED:| IMPLANTED: