BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3002361 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03656
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 20, 2013
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V758211, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEVER RECEIVED THERAPEUTIC EFFECT FROM THEIR DEVICE AND WAS NOT TRAINED ADEQUATELY ON USING THE DEVICE. IT WAS ALSO REPORTED THE PATIENT'S TRIAL "WENT GREAT" BUT AFTER THE TRIAL THE PATIENT DID NOT HAVE ANY RELIEF FOLLOWING THE PERMANENT IMPLANT. THE PATIENT HAD REPORTEDLY SEEN THEIR HEALTHCARE PROVIDER FOR REPROGRAMMING. IT WAS REPORTED THE PATIENT HAD A LEAD REVISION SURGERY IN (B)(6) 2012 AND IT DID NOT RESOLVE THE PATIENT'S CONCERNS. REFERENCE MANUFACTURER REPORT #3004209178-2013-03596 FOR INFORMATION FOLLOWING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105375 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention