BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3941505 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13146
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3093-33 LOT# V591580 IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-33 LOT# V591580 IMPLANTED: 2011-02-02 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID: 3095-10 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-33 LOT# V888674, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE DOCTOR WANTED SOMEONE TO VIEW THE X-RAYS AND ADVISE ON EXPLANTING ELECTRODES, WHICH APPEARED TO BE LOOSE ANTERIOR OF THE SACRUM. IT WAS NOTED THAT THE MANUFACTURER CANNOT READ RADIOGRAPHS OR PROVIDE MEDICAL ADVICE ON EXPLANTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALL WAS ABOUT A SURGICAL PROCEDURE. PHYSICIAN INFORMED CALLER TODAY THAT HE WANTS TO EXPLANT AN INTERSTIM SYSTEM FROM A PATIENT. THE CALLER THINKS THIS IS RELATED TO THE PATIENT NEEDING MRI OF SOME KIND, BUT CALLER NOT SURE. WHEN THE PHYSICIAN DID FLUORO IMAGES OF PATIENT, HE ONLY SAW SOME ELECTRODES AND ALL OTHER COMPONENTS WERE NOT PRESENT. THE PHYSICIAN WANTED ASSISTANCE TO LOOK AT FLURO TO INTERPRET WHAT'S LEFT INTERNALIZED. THE PHYSICIAN WANTED TO USE AN OLD TECHNIQUE OF REMOVING WHAT'S THERE BY GOING THRU ABDOMINAL AREA. IT WAS ALSO REPORTED THAT THE CALLER NOTED THAT A SURGEON CALLED ABOUT 5 MINUTES AGO. THERE WAS AN EXPLANT LAST WEEK. THE PREVIOUS SURGEON HAD IMPLANTED THE DEVICE ON THE PATIENT'S ABDOMEN. THIS NEW SURGEON EXPLANTED THE LEAD; ONLY SAW THE ELECTRODES UNKNOWN THE TYPE OF LEAD, X-RAY WAS DONE BUT HE HIMSELF DID NOT SEE IT. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE EXPLANTING PHYSICIAN HAD NOT EXPLANT ANYTHING YET. HE WAS AWAITING MEDICAL AFFAIRS TO CONSULT HIM ON X-RAYS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418422 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention