BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2211051 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-06086
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 15, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CHANGE IN THERAPY EFFECT WAS REPORTED INITIALLY ON (B)(6) 2011. THE PT WAS NO LONGER GETTING RELIEF LIKE SHE DID: EXPERIENCED PAIN IN CATHETER AREA, DIFFICULTY WALKING. THE PAIN WAS NEAR THE CATHETER PATHWAY, LOW BACK AND WAS NOTICED "THE OTHER DAY". THE PT HAD THE PAIN ISSUES LAST MONTH BUT ATTRIBUTED IT TO SOMETHING ELSE. SINCE THEN SHE COULD ONLY REMEMBER PICKING UP HER 35 LB GRANDSON. LATER ON (B)(6) 2011 PT EXPERIENCED SORENESS AND SWELLING AFTER MRI. IT WAS REPORTED THAT THE MRI TECHNICIAN HAD TO ADJUST SETTINGS AS INITIALLY SHE HAD THEM STOP THE MRI BECAUSE PT WAS EXPERIENCING EXTREME WARMTH OVER THE PUMP LOCATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR CTHETER: MODEL 8709SC, LOT #N252539004| IMPLANTED:| EXPLANTED: