BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1082612 · Received July 25, 2008

    Report

    Report Number
    6000032-2008-04394
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    December 1, 2003
    Report Date
    June 24, 2008
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED A NON-STANDARD NON-CONFORMANCE. THE LEAD WAS SEVERELY STRETCHED. THE #0 AND #1 CIRCUITS SHORTED DUE TO THE #0 CONNECTOR BEING PULLED OUT OF PLACE AND TOUCHING THE #1 CONNECTOR. THE #2 AND #3 CIRCUITS SHORTED AT THE #3 ELECTRODE DUE TO THE SEVERE STRETCHING OF THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING SHOCKING SENSATIONS AND HER LEAD WAS REPLACED. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO, MED REL 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention