BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3053008 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06014
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V501927, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THIS OCCURRED AFTER THE PATIENT HAD SURGERY ON HIS RIGHT FOOT ON (B)(6) 2013. THE PATIENT HAD TO KEEP HIS FOOT ELEVATED AND THUS HAD BEEN SITTING IN A RECLINER SINCE SURGERY UNTIL THE AFTERNOON OF (B)(6) 2013. THIS WAS WHEN THE PATIENT STARTED TO EXPERIENCE SEVERE PAIN AND A STABBING IN THE RIGHT LEG AND BACK, LIKE SPASMS. THE PAIN OCCURRED WHEN THE PATIENT MOVED, WALKED OR LIED DOWN. THE PATIENT DID NOT TURN OFF HIS DEVICE BEFORE THE FOOT SURGERY. THE PATIENT WAS THEN ASSISTED IN TURNING OFF HIS DEVICE, BUT THE PAIN AND SHOCKING PERSISTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155668 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR