BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2821692 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09976
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 10, 2012
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# J0427676V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD, PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT'S SYMPTOMS RECENTLY REOCCURRED. IT WAS NOTED THAT THE PATIENT HAD A MAJOR ACCIDENT AND HAD "MORE PROBLEMS THAN EVER" AS A RESULT, INCLUDING A LOSS OF BLADDER CONTROL. IT WAS STATED THAT DURING THE LAST SURGERY, THE DEVICE WAS TURNED OFF DUE TO "WORKING CLOSE TO THE WIRE." IT WAS INDICATED THAT THE DEVICE WAS TURNED BACK ON, BUT THE PATIENT STATED SHE DID NOT FEEL A STIMULATION SENSATION. AFTER INCREASING THE STIMULATION TO 2.05 VOLTS, THE PATIENT REPORTEDLY FELT STIMULATION. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1