BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATTRIX

    MDR report key: 1171398 · Received September 17, 2008

    Report

    Report Number
    2182207-2008-05852
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED MINOR SURGING. THE PATIENT DID NOT INDICATE THERE WAS AN INJURY ASSOCIATED WITH THE SURGING. A NEW ANTENNA WAS SENT TO THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL 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 MATTRIX LGW MEDTRONIC NEUROMODULATION 3272 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR EXPLANTED:| EXTENSION: MODEL 7495| IMPLANTED:| LEAD: MODEL 3998| LEAD: MODEL 3487A| TRANSMITTER: MODEL 3425| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| TRANSMITTER: MODEL 3210| IMPLANTED:| RECEIVER: MODEL 3470| IMPLANTED: