BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSENSOR KIT W/ SKULL BOLT

    MDR report key: 11273978 · Received February 3, 2021

    Report

    Report Number
    3013886523-2021-00054
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Report Date
    April 14, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS:  D4, D9, G3, G6, H2, H3, H4, H6, H10. THE MICROSENSOR WAS RETURNED FOR EVALUATION. REVIEW OF THE HISTORY DEVICE RECORDS FOR THE PRODUCT CODE 626638US WITH LOT 4850527 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - BASED ON THE SUPPLIER ANALYSIS AND INVESTIGATION, THE ISSUE OF THE COMPLAINT WAS NOT CONFIRMED: NO VISIBLE DAMAGE TO THE MILLAR SENSOR, CATHETER MATERIAL, OR CONNECTOR. ICP EXPRESS PASSED WITH A READING OF 494. THE DEVICE PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. THE ROOT CAUSE OF THE ISSUE REPORTED BY CUSTOMER COULD NOT BE DETERMINED AS THE DEVICE WORKED CORRECTLY. HOWEVER, THE POSSIBLE ROOT CAUSE FOR THIS ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO INCORRECT SET-UP OF DEVICE.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON JANUARY 8, 2021, A COMPLAINT WAS RECEIVED AGAINST TWO MICROSENSORS (HIGH NEGATIVE READINGS AND UNABLE TO ZERO [PRODUCT 626638US - LOTS 4850527 AND 4108613]). ON (B)(6) 2021, THE SALES REPRESENTATIVE INDICATES THAT INSTEAD OF 2 MICROSENSORS, THE PHYSICIAN RETURNED 3 (3RD MICROSENSOR HAS NO SPECIFIC FAILURE, OTHER THAN MALFUNCTIONED (PRODUCT 626653 - LOT J7211G), WITH AN ICP MONITOR (PRODUCT 826634 - SERIAL (B)(4)) AND A CABLE (PRODUCT 826636). THE MONITOR AND THE CABLE WERE USED TO TROUBLESHOOT WITH THE MICROSENSORS AND HE WANTED TO RETURN ALL PRODUCTS BECAUSE IS NOT CLEAR WHICH OF THE PRODUCTS MALFUNCTIONED. A PHONE CONVERSATION WITH THE SALES REP CONFIRMED THAT THERE ARE 3 MICROSENSORS, ONE MONITOR AND ONE CABLE. IT REMAINS UNKNOWN WHICH MICROSENSOR LOT HAD THE HIGH NEGATIVE READINGS, WHICH LOT WAS UNABLE TO ZERO AND WHAT WAS THE SPECIFIC FAILURE FOR THE THIRD MICROSENSOR. MICROSENSORS WERE USED IN DIFFERENT PATIENTS, AND THE CIRCUMSTANCES SURROUNDING THE EVENTS ARE ALSO UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172977 MICROSENSOR KIT W/ SKULL BOLT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1