BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2397465 · Received January 4, 2012

    Report

    Report Number
    3004209178-2012-00059
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Report Date
    December 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3093-28, LOT# V052572, IMPLANTED: (B)(6) 2007, EXPLANTED: NA, PROGRAMMER MODEL 3037, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ABOUT ONE TO TWO MONTHS AGO AND THEN NO LONGER FELT STIMULATION FROM HER IMPLANTABLE NEUROSTIMULATOR (INS). TWO TO THREE WEEKS AGO THE PATIENT LOST THERAPEUTIC EFFECT FROM HER INS. THE PATIENT WAS PROGRAMMED TO THE HIGHEST SETTING ON HER GROUP. THE PATIENT'S NORMAL SETTING WAS APPROXIMATELY 4.0V. NO FURTHER INFORMATION PERTAINING TO THE PATIENT'S STATUS WAS PROVIDED. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED. CAUSE OF EVENT: NOT FEELING STIMULATION. ABNORMAL IMPEDANCE MEASUREMENTS: NONE. NO INTERVENTIONS INCLUDING NO SURGICAL INTERVENTIONS PERFORMED. PROGRAMMER WORKING CORRECTLY. HOSPITALIZATION REQUIRED: NO. PATIENT OUTCOME: NO INJURY. THE PATIENT HAD AN APPOINTMENT ON 2012-(B)(6). INTERSTIM WAS REPROGRAMMED AT THAT TIME. PROGRAM WAS CHANGED FROM PROGRAM 2 TO PROGRAM 4 WITH AMP (V) FROM 6.0 TO 6.8. PATIENT FELT STIMULATION WELL AND WAS COMFORTABLE WITH IT. SYMPTOMS IMPROVING AFTER HEALTHCARE PROVIDE SPOKE WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1