BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3970636 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13749
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    April 21, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3023, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3080, LOT # L88126, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR FIRST DEVICE IMPLANTED IN 2007 OR 2008 AND THEY HAD THAT IMPLANT REPLACED ON (B)(6) 2014 DUE TO NORMAL BATTERY DEPLETION. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) INFORMED THE PATIENT ON THE SAME DAY THEY HAD THE IMPLANT REPLACED THAT THE PREVIOUS IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN LEAKING AND THERE HAD BEEN A LOT OF DEBRIS AROUND IT. IT WAS NOTED THAT THE HCP IRRIGATED IT WELL AROUND THAT AREA AND THE HCP DISCOVERED THAT THE INS HAD BEEN LEAKING ON THE DAY OF SURGERY. THE PATIENT WAS WONDERING IF THERE SHOULD BE ANYTHING THEY SHOULD BE CONCERNED WITH BECAUSE THEY HAD BEEN HAVING SOME HEALTH ISSUES. IT WAS REPORTED THAT THE PATIENT HADN¿T BEEN FEELING VERY WELL FOR A FEW MONTHS AND THE PAST MONTH HAD BEEN ROUGH. THE PATIENT WAS IN THE EMERGENCY ROOM (ER) WITH VERY LOW BLOOD PRESSURE AND A VERY LOW HEART RATE DOWN TO 30 AND THEN IT GOT HIGH. IT WAS STATED THAT THE PATIENT WAS IN THE ER EITHER ON (B)(6) 2014. THE PATIENT HAD NOT BEEN FEELING WELL FOR 6 TO 8 MONTHS BUT IT WASN¿T ANYTHING SERIOUS THEY JUST DIDN¿T FEEL WELL AND THEN ALL OF THE SUDDEN THEIR HEART RATE DROPPED TO 30 AND THAT WAS WHEN THEY ENDED UP IN THE ER. REFER TO MANUFACTURER REPORT # 3004209178-2014-13748 FOR THE PATIENT'S PREVIOUS SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DIDN¿T KNOW IF THEY HAD CONCERNS OR NOT. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) SAID THAT THEY DIDN¿T TELL THEM THAT THE DEVICE WAS LEAKING. THE HCP DID TELL THE PATIENT¿S SPOUSE THAT IT HAD BEEN LEAKING AND ALSO TOLD THEM. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446764 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention