BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1503506 · Received September 18, 2009

    Report

    Report Number
    3004209178-2009-06670
    Event Type
    Malfunction
    Date Received
    September 18, 2009
    Report Date
    August 21, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZM
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED INTERMITTENT STIMULATION AND A LOSS OF THERAPEUTIC EFFECT. SHE STATED THAT THE DEVICE HAS NOT BEEN WORKING FOR A YEAR. IT WAS ALSO STATED THAT THE PATIENT "HURT HER FOOT REALLY BAD". FURTHER INFORMATION WAS REQUESTED FROM THE HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZM MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM021792P| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH023361V| EXPLANTED:| EXPLANTED:| LEAD: MODEL LEAD URO, LOT# UNK