BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4101659 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17360
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # VA00A5S, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED LATER INDICATED THAT PATIENT'S STIMULATOR WAS STICKING OUT AND PAINFUL FOR A YEAR AND WHEN SHE FIXED IT THE HEALTH CARE PROVIDER STATED THE LEADS WERE IN A KNOT AND WERE LOOSE. IT WAS MENTIONED THAT PATIENT HAD PROBLEM WITH THEIR DEVICE SINCE IMPLANT. PATIENT STATED SHE HAD TO WAIT LONG TO HAVE IT REVISED AND WAS RIDICULOUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A SURGICAL PROCEDURE TO REPAIR THE LEAD ON (B)(6) 2014. IT WAS NOTED THAT THE LEAD WAS "ALL TWISTED UP." THE PATIENT WAS UNSURE IF THE HEALTH CARE PROVIDER (HCP) ACTUALLY REPLACED THE LEAD OR JUST STRAIGHTENED OUT THE CURRENT LEAD. IT WAS NOTED THE THERAPY WAS TURNED OFF BEFORE THE SURGERY AND WHEN PATIENT WENT TO TURN STIMULATION BACK ON IT SAID IT NEEDED TO BE REPROGRAMMED. THE PATIENT HAD PAIN DUE TO LEADS BEING TWISTED AND HAD A KNOT IN HER REAR END. THE PATIENT INDICATED THAT IT STARTED AS SOON AS SHE GOT THE DEVICE. THE PATIENT STATED SHE HAD A HARD TIME CONVINCING THE HCP THAT IT WAS NOT WORKING. THE PATIENT REPORTED THAT THE KNOT WAS PAINFUL IF SHE SAT OR LIE DOWN BECAUSE IT WOULD PULL. THE PATIENT INDICATED THAT SHE HAD THREE BAD FALLS SINCE SHE HAD THE IMPLANT AND HAD TO HAVE SURGERIES. FIRST FALL WAS AT THE END OF AUGUST THE SECOND FALL WAS ON CHRISTMAS EVE AND THE THIRD FALL WAS CLOSE TO EASTER. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD LOOKED TWISTED BUT INTACT. THE CAUSE WAS THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS MOBILE AND WAS TWISTING IN THE POCKET AND THE PATIENT HAD A HISTORY OF FALLS. NOT ALL PARTS OF THE LEAD WERE EXPLANTED AND THE LEAD APPEARED INTACT. THE TROUBLESHOOTING, INTERVENTIONS, OR OTHER ACTIONS TAKEN TO RESOLVE THE EVENT WERE X-RAYS, THE PROGRAMMING WAS CHECKED, AND THE INS WAS REVISED AND FIXED TO THE GLUTEAL FASCIA AND THE LEAD WAS UNTWISTED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584739 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention