BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5016112 · Received August 19, 2015

    Report

    Report Number
    3004209178-2015-16327
    Event Type
    Injury
    Date Received
    August 19, 2015
    Date of Event
    June 26, 2015
    Report Date
    July 24, 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
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # V850461, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT (B)(6). (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REPORTED THAT THERE WERE NO SYMPTOMS RELATED TO THE REPORTED BATTERY DEPLETION. THE CAUSE OF THE BATTERY DEPLETION WAS DETERMINED TO BE DUE TO THE PATIENT HAD PSYCHIATRIC ILLNESS EXACERBATE AND DEMANDED THE INTERSTIM BE REMOVED.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED VIA A MEDWATCH THAT A PATIENT IMPLANTED FOR GASTROINTESTINAL/PELVIC FLOOR HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) MALFUNCTION DUE TO A DEPLETED BATTERY. IT WAS NOTED THAT THE DEVICE FAILED AND WAS REMOVED. NO FOLLOW-UP CONTACT, EVENT CAUSE, SYMPTOMS, OR TROUBLESHOOTING WERE REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. SEE ATTACHED USER FACILITY MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549811 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention