BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3181816 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10689
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 30, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# VA06EVY, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT¿S DEVICE WAS IMPLANTED IN A DIFFERENT POCKET THAN THE PATIENT¿S PREVIOUS DEVICE. THE DEVICE WAS IMPLANTED IN A POCKET ON THE PATIENT¿S LEFT SIDE, IN THE UPPER BUTTOCK AREA. IT WAS NOTED THAT THE PATIENT STATED, IT HAD NEVER FELT SO COMFORTABLE AND THAT THEY COULD ¿BARELY FEEL IT.¿ AFTER IMPLANT, IT WAS STATED, THE PATIENT FELL AND REOPENED THE INCISION. THE DEVICE WAS ¿POKING THROUGH¿ AND THE PATIENT WAS IN TERRIBLE PAIN. ADDITIONAL INFORMATION RECEIVED INDICATED, THE PATIENT RECEIVED ASSISTANCE FROM THEIR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS ALSO NOTED THAT THE PATIENT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE TO RESOLVE OTHER CONCERNS. AN APPOINTMENT FOR (B)(6) 2013 WAS NOTED. IT WAS THEN REPORTED THAT THE PATIENT FELL AND THE DEVICE BECAME MOBILE CAUSING PAIN. A SURGICAL INTERVENTION WAS NOTED FOR (B)(6) 2013, WHEREIN THE PATIENT¿S DEVICE WAS REPLACED. IT WAS NOTED THAT THE PATIENT¿S PHYSICIAN REVISED THE GENERATOR LOCATION AND THE RESULTS WERE GOOD. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THE PATIENT OUTCOME WAS REPORTED AS SERIOUS ILLNESS/INJURY RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT FELL IN (B)(6) 2013 "AND I CRUSHED THE STIMULATOR I HAD IN AT THAT TIME, SO THEY HAD TO REPLACE IT IN (B)(6) 2013".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CAUSE OF THE EVENT WAS A FALL. RADIOLOGICAL EVALUATION: KUB SHOWED LEADS IN PROPER POSITION. THIS IS A PATIENT WITH MULTIPLE NEUROLOGIC/ORTHOPEDIC ISSUES. SHE WILL RESUME INTERSTIM AFTER MANAGEMENT OF HER OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282245 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention