BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1091505 · Received August 1, 2008

    Report

    Report Number
    3004209178-2008-04595
    Event Type
    Injury
    Date Received
    August 1, 2008
    Report Date
    July 2, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED SHOCKING SENSATIONS AND OVERSTIMULATION FROM HER DEVICE. REPROGRAMMING WAS DONE MULTIPLE TIMES WITHOUT SUCCESS. THE PT UNDERWENT A LEAD REVISION IN 2003 TO ATTEMPT TO RESOLVE THE ISSUE, BUT THE SHOCKING PERSISTED. THE PT TURNED HER DEVICE OFF IN 2007 AS IT "WAS NOT WORKING WELL". NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT| IMPLANTED| EXPLANTED| EXTENSION MODEL 3095| LEAD MODEL 3886| EXPLANTED