BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3823647 · Received May 21, 2014

    Report

    Report Number
    3004209178-2014-09332
    Event Type
    Injury
    Date Received
    May 21, 2014
    Report Date
    August 25, 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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-33, LOT # V152636, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT # V152636, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    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 REPORTED THAT ALL OF THE IMPLANTABLE NEUROSTIMULATOR (INS) COMPONENTS HAD BEEN EXPLANTED EXCEPT FOR A PARTIAL LEAD WHICH THE PATIENT¿S HEALTH CARE PROVIDER (HCP) CHOSE NOT TO REMOVE OR CHOSE NOT TO TUNNEL TO REMOVE. THE PATIENT WAS WONDERING IF THEY COULD HAVE AN MRI WITH THE PARTIAL LEAD IMPLANTED. IT WAS NOTED THAT THE PATIENT¿S SECOND IMPLANT WAS DONE IN 2012 AND USED THE SAME LEADS AS THE FIRST IMPLANT IN 2008. THE IMPLANT WAS EXPLANTED BECAUSE IT WASN¿T GETTING CAPTURE AND THE LEADS WERE BROKEN AND NOT FUNCTIONING. IT WAS REPORTED THE ONLY PART OF THE INS SYSTEM THAT REMAINED IN THE PATIENT¿S BODY WAS A PORTION OF THE LEAD THAT THE HCP REFUSED TO TUNNEL TO REMOVE. THE LEAD THAT WAS PARTIALLY LEFT IN WAS FROM THE INITIAL IMPLANT IN 2008.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT ONE OF THE WIRES BROKE OFF, AND THEY COULD NOT GET IT OUT UNLESS THEY DO A MAJOR SURGERY, BUT THEIR HEALTH DOES NOT ALLOW THAT, SO THE PATIENT STILL HAD WIRES ON THE LEFT SIDE OF THEIR PELVIS. IT WAS NOTED THAT THE HEALTHCARE PROFESSIONALS ¿MADE 2-3 ATTEMPTS, DECLINED TO GET THE WIRES OUT, AND THE PATIENT DID NOT WANT THE HEALTHCARE PROVIDER TO DIG ANYTHING OUT OF THEIR BACK. IT WAS ALSO STATED THAT THE WIRES ¿RUSTED OUT;¿ THEY WERE RUSTED, EMBEDDED IN THE TISSUE, IN THE MUSCLES OF THEIR BACK. THEY WERE GOING TO REDO THEM, BUT ¿IT¿S ANOTHER STORY.¿ NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301810 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention