BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4806271 · Received May 29, 2015

    Report

    Report Number
    3004209178-2015-09975
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Report Date
    May 7, 2015
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V896802, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BACK PAIN AND GROIN PAIN. THE LOW BACK PAIN HAD BEEN PRESENT FOR 2 TO 3 WEEKS AND STARTED AFTER KNEE SURGERY. THE PATIENT HAD AN ELECTIVE KNEE REPLACEMENT SURGERY ON (B)(6)2015. THEIR STIMULATOR WAS NOT TURNED OFF FOR THE SURGERY. ON THE SECOND DAY AFTER THE OPERATION THE PATIENT HAD BILATERAL MEDIAL THIGH PAIN THAT WAS TERRIBLE LIKE MUSCLE CRAMPING AND SPASMS. THE ISSUES WERE INSIDE THE SOFT TISSUE FROM THE THIGH TO THE BUTTOCK AREA. IT WAS UNKNOWN IF ELECTROCAUTERY WAS USED FOR THE KNEE REPLACEMENT. THE PATIENT TURNED THEIR STIMULATOR OFF ON (B)(6) 2015 AND SINCE THEN THEY FELT LIKE A BRAND NEW PERSON. NO INTERVENTIONS OR OUTCOME WERE 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
    349839 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR