BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2916446 · Received January 15, 2013

    Report

    Report Number
    3004209178-2013-00613
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Report Date
    December 31, 2012
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V062916, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A 'FEMALE SURGERY' A FEW WEEKS PRIOR AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF FOR THE SURGERY. THE INS WAS TURNED BACK ON AFTER SURGERY AND THE PATIENT STARTED HAVING PAIN FROM THEIR INS IMPLANT SITE DOWN TO THEIR FEET. IT WAS ALSO NOTED THE PATIENT STARTED HAVING LEG PAIN AT THIS TIME. THE PATIENT TURNED THE INS OFF AND REPORTED NOT HAVING THE PAIN IN THEIR LEG BUT THEY WERE STILL HAVING PAIN 'WHERE THE SITE WAS' WHEN THEY WALKED. IT WAS NOTED AS MORE 'SHARP PAINS AROUND THE IMPLANT SITE' AND THAT IT IS 'NOT REALLY A SHOCK.' THE PATIENT HAD 5 OR 6 X-RAYS AND THEIR HEALTH CARE PROVIDER THOUGHT THEY MAY HAVE OSTEOARTHRITIS AND WANTED THE PATIENT TO SEE A 'BONE DOCTOR.' ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22440 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1