BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1172906 · Received September 19, 2008

    Report

    Report Number
    3004209178-2008-05944
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SEE ALSO MANUFACTURER REPORT 3004209178200805974. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION AT LEAST TWICE A DAY AND PAIN/DISCOMFORT AT THE LEAD SITE THAT RADIATED DOWN THE LEGS. SHE WAS TOLD DURING RECENT SURGERY THAT HER LEAD HAD MIGRATED FROM ITS ORIGINAL IMPLANT LOCATION . FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889| PROGRAMMER: MODEL 3037| IMPLANTED:| EXTENSION: MODEL 3095