BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1172899 · Received September 19, 2008

    Report

    Report Number
    2182207-2008-05955
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS NOT HAD THERAPEUTIC EFFECT FOLLOWING PUMP IMPLANT. THE PT WAS "IN A LOT OF PAIN". THE RESERVOIR VOLUME WAS CHECKED AND THEY "HAD MORE VOLUME THAN EXPECTED." NO DIAGNOSTIC STUDIES HAVE BEEN PERFORMED. THE HCP HAD RECOMMENDED PERFORMING A DYE STUDY. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL# 8709SC CATHETER| PROGRAMMER: MODEL PROGRAMMER