BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5729472 · Received June 16, 2016

    Report

    Report Number
    3004209178-2016-12337
    Event Type
    Injury
    Date Received
    June 16, 2016
    Date of Event
    May 20, 2016
    Report Date
    July 12, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37092, PRODUCT TYPE: ACCESSORY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT PATIENT FIRST EXPERIENCED LEAKING AND UNABLE TO TURN UP DEVICE IN (B)(6) 2016.THE MANUFACTURER COMPANY WAS CALLED WHEN THE UNIT WOULD NOT SYNC WITH IMPLANT. THE UNIT WAS REPLACED AND ANTENNA WAS ALSO REPLACED BUT DID NOT SYNC. IT WAS REPORTED THAT THE LEAKING AND THE UNABLE TO TURN UP DEVICE HAS NOT BEEN RESOLVED. THE PATIENT WAS TOLD THE IMPLANT BATTERY WAS DEAD AND WOULD HAVE TO BE REPLACED SURGICALLY. THE PATIENT APPOINTMENT WITH DOCTOR WAS ON (B)(6) 2016 FOR PRE-SURGICAL CONSULT.

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT A FEW DAYS PRIOR TO THE REPORT THEIR PROGRAMMER WILL NOT CONNECT WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH OR WITHOUT THE ANTENNA. THEY CONFIRMED THE PROGRAMMER HAS NOT BEEN DROPPED OR GOTTEN WET. THE PATIENT ADDED THAT BEFORE THE IMPLANT THEY WERE LEAKING ALL THE TIME; AFTER THE IMPLANT, THEY ONLY LEAKED WHEN SHE WOULD COUGH. HOWEVER, THE PATIENT STATES THAT THEY HAVE HAD A SUDDEN RETURN OF SYMPTOMS. THEY KEEP THEIR PROGRAMMER IN THE DRAWER AND HAS NOT USED IT FOR APPROXIMATELY 18 MONTHS, SO THEY DON'T THINK THEY STIMULATION IS TURNED OFF. THE LEAKING STARTED A COUPLE OF WEEKS OR 2 WEEKS PRIOR TO THE REPORT, ACCORDING TO THE PATIENT. A NEW PROGRAMMER WAS SENT TO THE PATIENT AND THEY LATER REPORTED THAT THE REPLACEMENT PROGRAMMER STILL WAS NOT WORKING WITH THEIR ANTENNA. A NEW ANTENNA WAS SENT TO THE PATIENT. THE PATIENT WONDERED IF IT WAS AN ISSUE WITH THE INS ITSELF. ADDITIONAL FOLLOW UP INFORMATION FROM THE PATIENT REPORTED THE PATIENT WAS SEEN IN THE HEALTHCARE PROVIDERS (HCP) OFFICE AND THEY WERE UNABLE TO SYNC THE UNIT. THEY NOTED THEIR NEXT STEP IS TO SEE THEIR HCP TO REPLACE THE "BATTERY," AND SAID "IT APPEARS SURGERY IS IMMINENT." THE INS IS INDICATED FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION/GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385235 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention