BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2152321 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04697
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED PAIN AND SENSITIVITY AT THE LEAD INSERTION SITE. SHE FELT A SHOCKING SENSATION FROM THE DEVICE. THE LEAD WAS BROKEN AND PALPABLE THROUGH THE SKIN AT THE LEAD INSERTION SITE. THE PT DISCONTINUED THE STIMULATION. SHE WAS INJECTED WITH LIDOCAINE 1% AND 3 CCS OF MARCAINE. A LEAD REVISION WAS TO BE SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V327760| PROGRAMMER: MODEL 3037, LOT# NJD088108N| PROGRAMMER: MODEL 3037, LOT# NJD088108N| LEAD: MODEL 3093, LOT# V327760| EXPLANTED:| IMPLANTED: