BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 7074737 · Received December 1, 2017

    Report

    Report Number
    3004209178-2017-24683
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    January 1, 2010
    Report Date
    December 1, 2017
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE:PRODUCT ID 3889, LOT# J0436980V, IMPLANTED: (B)(6) 2004 EXPLANTED: (B)(6) 2010 PRODUCT TYPE LEAD PRODUCT ID 3889-28 LOT# J0436980V SERIAL# IMPLANTED: 2004-09-22, EXPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT STATED THE DEVICE SHE HAD IMPLANTED IN 2004 WORKED GREAT UNTIL SOMETIME IN 2010. PATIENT STATED SHE MOVED TO (B)(6) AND SHE NOTICED THE DEVICE WASN'T WORKING AS EFFECTIVELY. PATIENT STATED THEY THOUGHT THE LEAD MIGRATED OR SEPARATED FROM THE BATTERY. PATIENT STATED SHE THOUGHT IT WAS DETERMINED THE LEAD SEPARATED FROM THE BATTERY, SO THE STIMULATION WAS GOING INTO THE TISSUE AND NOT INTO THE WIRE. PATIENT STATED SHE HAD THE DEVICE ADJUSTED OR REPLACED IN 2010. THE PATIENT INDICATORS USE ARE FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856292 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention