BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2842966 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10690
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE DEVICE, MODEL # 3058, SERIAL # (B)(4), FOUND THAT THE GROMMET WAS DAMAGED, THE SETSCREW WAS NOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SETSCREW ISSUE WITH AN OUT OF BOX DEVICE. THE REPORTER STATED THE SETSCREW "WOBBLED AROUND AND WOULD NOT TORQUE." IT WAS FURTHER STATED THAT NO RETRACTION OF THE SETSCREW WAS DONE PRIOR TO EVENT. IT WAS NOTED THAT A SECOND TORQUE WRENCH WAS USED WITH THE SAME RESULT. THE REPORTER THEN STATED THAT THE SETSCREW WAS FULLY RETRACTED AND LOST. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A SECOND DEVICE WAS USED AND THE SETSCREW WORKED "FINE." NO PATIENT INJURY WAS ASSOCIATED WITH THIS EVENT. THE OUTCOME WAS STATED AS "ALL GOOD WITH THE PATIENT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1