BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3329765 · Received September 6, 2013

    Report

    Report Number
    3004209178-2013-15772
    Event Type
    Malfunction
    Date Received
    September 6, 2013
    Report Date
    August 12, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-33, LOT# V833270, IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ¿WISHED TO HELL¿ THAT THEY ¿NEVER HAD IT IMPLANTED.¿ IT WAS NOTED THAT IT DID NOT WORK FOR THE PATIENT. THE PATIENT ¿WENT BACK FOR MONTHS¿ BUT IT WOULD NOT WORK. THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN OFF SINCE THE LAST TIME THE PATIENT HAD SEEN THE HEALTHCARE PROFESSIONAL (HCP) BUT THE PATIENT DID NOT REMEMBER WHEN THAT WAS. THE PATIENT NOTED THEY HAD A ¿BAD HOSPITALIZATION¿ AND WAS IN THE HOSPITAL AND REHABBED FOR ONE MONTH. THE PATIENT NOTED THAT THEY DID NOT RECOMMEND ¿THIS¿ TO ANYONE. THE EVENT OR SYMPTOM OCCURRED FOLLOWING IMPLANT. THE PATIENT INQUIRED ABOUT INS REMOVAL. THE PATIENT WAS REDIRECTED TO THE HCP. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443670 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR