BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3074652 · Received April 24, 2013

    Report

    Report Number
    3004209178-2013-06812
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V913912, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A POCKET REVISION ON A FRIDAY, THE DATE WAS UNKNOWN. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REVISED BECAUSE THE PATIENT THOUGHT THE INS WAS 'TOO SUPERFICIAL' AND IT WAS CAUSING PAIN WHEN PALPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 2013 (B)(6) WHICH NOTED THAT THE POCKET REVISION WAS DONE ON 2013 (B)(6) AND THE PATIENT WAS PLEASED WITH THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177446 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention