BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1932050 · Received November 30, 2010

    Report

    Report Number
    3004209178-2010-10045
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDTRONIC 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT WAS USING THE DEVICE FOR RETENTION AND NOW HAD INCONTINENCE WITH UNCOMFORTABLE STIMULATION AROUND THE RECTAL AREA. SHE HAD TURNED THE DEVICE OFF FOR THE LAST FEW DAYS AND THE DISCOMFORT WAS GONE, BUT STILL HAD THE INCONTINENCE ISSUE. SHE SUBSEQUENTLY EXPERIENCED A SHOCKING/JOLTING SENSATION AND PAIN NEAR THE RECTUM. THE PT HAD AN APPOINTMENT WITH HER PHYSICIAN ON (B)(6) 2010 AND DESIRED TO HAVE THE DEVICE REMOVED. ADDITIONAL INFO WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR PROGRAMMER: MODEL 3031A, LOT# NGM024910P| EXPLANTED:| LEAD: MODEL 3889, LOT# J0555163V| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH026004V| IMPLANTED:| EXPLANTED: