BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4730731 · Received April 27, 2015

    Report

    Report Number
    3004209178-2015-07946
    Event Type
    Injury
    Date Received
    April 27, 2015
    Date of Event
    April 2, 2015
    Report Date
    April 6, 2015
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-33, LOT# V103841, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3037,SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PROGRAMMER WAS NOT WORKING. THE PATIENT COULD NOT CONNECT TO CHECK THE STATUS OF THE STIMULATOR. THE POOR COMMUNICATION SCREEN KEPT APPEARING ON THE PROGRAMMER BOTH WITH AND WITHOUT THE ANTENNA ATTACHED. REPLACING THE BATTERIES DID NOT RESOLVE THE ISSUE. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND STIMULATION SENSATION. THEY HAD BEEN HAVING ACCIDENTS ALL DAY LONG. THE ACCIDENTS WERE KEEPING THEM UP AT NIGHT. UPON RECEIVING THE REPLACEMENT PROGRAMMER, IT ALSO DID NOT WORK. THE POOR COMMUNICATION SCREEN WAS PRESENT. THE ISSUES WERE DETERMINED A MALFUNCTION AND EXPLANT WAS PLANNED. NO OUTCOME WAS 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
    275272 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention