BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3896935 · Received June 26, 2014

    Report

    Report Number
    3004209178-2014-12087
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V183293, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-28, LOT# V183293, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A LETTER SAYING THAT PATIENT SERVICES WAS HERE TO ANSWER QUESTIONS. THE PATIENT HAD SEVERAL SURGERIES AND IN 2008 THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PUT IN. IT WAS NOTED THAT THEN IN (B)(6) 2009, THE PATIENT WENT IN FOR A REVISION AND COULD NOT RECALL THE REASON FOR THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374746 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention