BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3530286 · Received December 20, 2013

    Report

    Report Number
    3004209178-2013-23816
    Event Type
    Injury
    Date Received
    December 20, 2013
    Report Date
    December 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3889-28, LOT# V914059, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3889-28, LOT# V864270, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INS WAS "POKING OUT" AND WAS NO LONGER LAYING FLAT. THE PATIENT NOTED: "IT SEEMS LIKE IT SLIPPED OUT OF WHERE IT'S SUPPOSE TO BE". REGARDING WHEN DID THE EVENT OR SYMPTOMS OCCUR, IT WAS NOTED "LAST NIGHT" . REGARDING IF THE PATIENT HAD ANY FALLS OR TRAUMA, IT WAS NOTED: "YES." REGARDING IF THE PATIENT HAD HER INS CHECKED AT ALL AFTER THOSE FALLS, IT WAS NOTED SHE HAD NOT. THE PATIENT WAS LOOKING FOR A NEW HEALTHCARE PROVIDER AS HER HEALTHCARE PROVIDER RETIRED AND THE PHONE NUMBER WAS DISCONNECTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2013-23815.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT GOT INTO A FIGHT IN (B)(6) 2013 AND NOW HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS LOOSE IN THE POCKET. THEY SUSPECTED SUTURES BROKE. THE INS WAS FLOATING AND WAS GETTING CAUGHT ON CHAIRS, ETC. THEY HAD A LOOSE BANDAGE TO HELP SECURE AT THE MOMENT. PATIENT WAS CURRENTLY AT A DRUG AND ALCOHOL REHABILITATION CENTER. THE REPORTER NEEDED A NEW HCP (HEALTHCARE PROVIDER) TO REVISE THE POCKET. THE REPORTER WANTED THE POCKET REVISED BEFORE THE PATIENT GETS OUT OF TREATMENT TO PREVENT PAIN MEDICATION NEEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669045 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention