BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4210315 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20591
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    September 27, 2018
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# VA0ENM4, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    DUE TO INDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSIONS CODES NO LONGER APPLY TO THIS EVENT. (B)(4) NO LONGER APPLIES TO THE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING DEVICE IMPLANT A DOCTOR DIDN¿T CLOSE A PATIENT AFTER SURGERY AND THE PERSON WHO DID CLOSE THE PATIENT DIDN¿T DO IT RIGHT. A WEEK LATER THE DOCTOR HAD TO PUT STITCHES IN. A MANUFACTURER REPRESENTATIVE GAVE THE PATIENT INSTRUCTIONS WHEN HE WAS HALF CONSCIOUS AFTER THE SURGERY. THE PATIENT WAS BASICALLY HAPPY WITH THE DEVICE, BUT IF HE WAS SEXUALLY STIMULATED OR CLOSE TO AN ORGASM HE WOULD GET THE WORST SHOCK. IT WAS LIKE LIGHTNING STRUCK HIM, IT WAS AWFUL, AND IT WAS WORSE THAN ANYTHING IN HIS LIFE ALTHOUGH HE¿D BEEN THROUGH CANCER AND A LOT OF PAIN. THE ISSUE MADE THE PATIENT AFRAID TO HAVE SEX. THE PATIENT STARTED GETTING STRANGE SHOCKS WHEN HE GOT AROUSED SEVERAL MONTHS AGO AND THE FIRST TIME HE TRIED FOUR TO SIX WEEKS AGO, HE GOT THAT AWFUL SHOCK. IF THE PATIENT PICKED UP SOMETHING HEAVY, IT WAS PAINFUL AFTERWARD. HE WAS QUESTIONING HIS LEADS BECAUSE OF HOW HE FELT WHEN LIFTING. IF THE PATIENT CARRIED 40 POUNDS, IT TOOK THREE DAYS TO SETTLE DOWN. HE HADN¿T CHANGED PROGRAMS AND WAS AFRAID TO CHANGE IT AGAIN. THE PATIENT KEPT IT ON A PARTICULAR PROGRAM BECAUSE IT WAS WORKING WELL. WHEN THE PATIENT CHANGED PROGRAMS IT WAS LIKE TRYING TO GET HIT BY LIGHTNING. THE PATIENT HADN¿T CONTACTED HIS PHYSICIAN ABOUT THE ISSUE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693358 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR