BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INTERFACE 8253200 RESPONSE 3.0

    MDR report key: 2884031 · Received December 21, 2012

    Report

    Report Number
    1045254-2012-00757
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC INC
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE COMPLAINT DEVICE WAS EVALUATED. THE PATIENT INTERFACE STIM 2 WAS CONFIRMED AS NOT WORKING. EVALUATION CONCLUDED THIS WAS DUE TO A SHORT IN THE CABLE. THE CABLE WAS REPLACED AND THE UNIT WAS TESTED AND PERFORMED TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    EVENT DATE - (B)(6) 2012. UPON FINAL REVIEW OF THE FILE FOR CLOSURE, IT WAS DISCOVERED THAT THIS UNIT IS USED IN THE MANUFACTURER'S SERVICE AND REPAIR DEPARTMENT. THIS EQUIPMENT IS USED FOR TESTING PURPOSES ONLY. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC THAT STIM 2 ON A PATIENT INTERFACE WAS NOT WORKING. THERE WAS NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 1

    UPON FINAL REVIEW OF THE FILE FOR CLOSURE, IT WAS DISCOVERED THAT THIS UNIT IS USED IN THE MANUFACTURER'S SERVICE AND REPAIR DEPARTMENT. THIS EQUIPMENT IS USED FOR TESTING PURPOSES ONLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT INTERFACE 8253200 RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC INC 8253200 205411890

    Patients

    Seq Age Sex Outcome Treatment
    1