BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENA MUSCLE STIMULATOR PROBE (NOT STERILE)

    MDR report key: 3902049 · Received February 24, 2014

    Report

    Report Number
    9612007-2014-00009
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Report Date
    January 29, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE EIGHTH REPORT OF EIGHT FROM THE SAME FACILITY INVOLVING PENA PROBE. CROSS REFERENCE WITH MFR. REPORT 9612007-2014-00003. A REPORT WAS RECEIVED FROM A CHILDREN'S HOSPITAL THAT THE PENA PROBE STOPPED/DIDN'T WORK. THE CONSULTANT SURGEON CUT THE CABLE AND EXPOSED THE INNER CABLING WHICH APPEARED TO BE OXIDIZED. THE PROBE WAS IN CONTACT WITH A PATIENT (AGE OF THE PATIENT IS NOT AVAILABLE). THERE WAS A DELAY WHILE THE STAFF LOCATED ANOTHER PROBE TO USE. THERE WAS NO INJURY INVOLVED AS A RESULT OF THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114447 PENA MUSCLE STIMULATOR PROBE (NOT STERILE) PENA MUSCLE STIMULATOR PROBE IPF INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1