BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1081329 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04348
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    January 23, 2008
    Report Date
    June 27, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT SHE HAD EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOR APPROX THE PAST TWO WEEKS AND HAD NOTICED SWELLING NEAR HER CATHETER SITE. THE PT WAS ENCOURAGED TO CONTACT HER HEALTH CARE PROFESSIONAL (HCP). FOLLOW-UP WITH THE HCP PROVIDED THAT THE PT WAS DIAGNOSED WITH A PSEUDOMENINGOCELE. THE LUMBAR INCISION WAS REVISED ON APPROX ONE AND A HALF MONTHS EARLIER. THERE WAS APPARENT LEAKAGE OF CEREBRAL SPINAL FLUID AROUND THE CATHETER INTO THE SUBCUTANEOUS TISSUES; THIS APPEARED TO BE SLOWING IMPROVING. THE PT SYMPTOM WAS REPORTED TO BE EDEMA; THE LOSS OF THERAPEUTIC EFFECT HAD NEVER BEEN REPORTED TO THE HCP. THE PT OUTCOME WAS REPORTED AS "NON-SERIOUS INJURY/ILLNESS". THE PUMP WAS USED TO DELIVER LIORESAL 500 MCG/ML AT 140 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| CATHETER MODEL 8709SC LOT# N127444025| EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNKNOWN