BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3984682 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14032
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V955729, IMPLANTED:(B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION 2 WEEKS AGO. THE PATIENT STATED THAT THEY ¿DIDN¿T KNOW HOW MUCH SHE NEEDED¿ THEIR IMPLANTABLE NEUROSTIMULATOR (INS) UNTIL THEY HAD AN INFECTION. THE PATIENT LOST THEIR PROGRAMMER UNIT AND DOESN¿T REMEMBER THE LAST TIME THEY USED IT. A REPLACEMENT UNIT WAS THEN ORDERED FOR THE PATIENT AND THAT THEY WILL ¿DEVICE PROGRAM¿ WHEN THEY GET THE UNIT. FOLLOW-UP IS BEING CONDUCTED FOR CLARIFICATION. THERE WERE NO FURTHER INTERVENTIONS OR OUTCOME REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460089 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention