BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2230753 · Received August 23, 2011

    Report

    Report Number
    3004209178-2011-06748
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DID NOT BELIEVE THEIR PUMP WAS EFFECTIVE. THE PUMP WAS EXPLANTED ON (B)(6) 2011. IT WAS LATER REPORTED THAT THERE WAS A SUSPECTED CATHETER BREAK AT AN UNKNOWN LOCATION. BACLOFEN COULD NOT BE ASPIRATED FROM THE PORT DURING A CATHETER DYE STUDY ((B)(6) 2010). ON THAT SAME DAY A PUMP ROTOR STUDY WAS NORMAL. THE PATIENT WAS TAPERED OFF THE LIORESAL; PRESERVATIVE-FREE 0.9 NORMAL SALINE WAS USED IN THE PUMP. THE PATIENT "CONTINUED UPPER AND LOWER EXTREMITY TONE" DURING THE DRUG TAPER. THE PATIENT WAS NOT HOSPITALIZED; NO INJURY WAS REPORTED FOR THE PATIENT. THE PATIENT OUTCOME FOLLOWING THE EXPLANT WAS REPORTED AS NO INJURY.

    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 20 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N110183021| IMPLANTED: