BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2951052 · Received February 8, 2013

    Report

    Report Number
    3004209178-2013-01505
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 22, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V826029, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND THE PATIENT STATED THAT HER DEVICE AFFECTED HER RECTUM AND NOT HER BLADDER. SUBSEQUENT INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING CONCERNS WITH HER DEVICE OR THERAPY, BUT WAS WORKING WITH HER DOCTOR AND/OR MANUFACTURER REPRESENTATIVE. INFORMATION RECEIVED FROM THE PATIENT'S DOCTOR REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN, THERE WERE NO ABNORMAL IMPEDANCES, NO HOSPITALIZATION WAS REQUIRED, AND THAT THE PATIENT WAS REFERRED TO ANOTHER DOCTOR FOR CYSTOCELE AND POSSIBLE SURGERY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT REPORTED HAVING SURGERY SIX MONTHS AGO TO HAVE THE "DEVICE REWIRED" AND THE PATIENT STATED THAT "IT'S NOT WORKING AS WELL AS IT DID." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE STEPS TAKEN TO RESOLVE THE PATIENT'S LACK OF THERAPEUTIC EFFECT WERE REPEATED SURGERIES AND ADJUSTMENTS THAT FAILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE DEVICE NEVER WORKED. AFTER THE PATIENT HAD 3 SURGERIES TO MAKE IT WORK, IT NEVER DID. IT WAS NOT WORKING AND HAD BEEN OFF FOR 2 YEARS. THE PATIENT WANTED THE DEVICE REMOVED SO THEY COULD HAVE AN MRI. THE INDICATIONS FOR USE FOR THIS PATIENT WERE URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54955 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention