BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3008678 · Received March 18, 2013

    Report

    Report Number
    3004209178-2013-03845
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Report Date
    February 26, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V120752, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT NO STIMULATION. IT WAS STATED THAT THE PATIENT COULD NOT COMMUNICATE WITH THEIR PROGRAMMER. IT WAS NOTED THAT THE PATIENT STATED "IT SERVED NO PURPOSE EVERY TIME I HURT IT WAS A STONE OR SOMETHING ELSE." THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 NOTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS CURRENTLY ON AMPLITUDE 3.6 AND PROGRAM # 3. NO SURGICAL INTERVENTION OCCURRED. ON (B)(6) 2013, THE PATIENT'S PROGRAM WAS SWITCHED TO PROGRAM # 3. SIGNS AND SYMPTOMS INCLUDED DECREASED SENSATION OF DEVICE. HOSPITALIZATION WAS NOT REQUIRED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111387 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1