BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSENSOR KIT W/ SKULL BOLT

    MDR report key: 12250483 · Received July 29, 2021

    Report

    Report Number
    3013886523-2021-00338
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    July 11, 2021
    Report Date
    December 16, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS:  D4, D9, G3, G6, H2, H3, H4, H6, H10. THE MICROSENSOR WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE LOT 4143348 (SN (B)(6)) MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE ISSUE OF THE COMPLAINT WAS NOT CONFIRMED. NO VISIBLE DAMAGE TO THE MILLAR SENSOR, CATHETER MATERIAL, OR CONNECTOR. ICP EXPRESS PASSED WITH READING 484. 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

    A FACILITY REPORTED INCONSISTENT READINGS FROM AN INTRACRANIAL PRESSURE MICROSENSOR. THE PATIENT HAD A CODMAN MICROSENSOR METAL SKULL BOLT IMPLANTED ON (B)(6) 2021 AFTER IT WAS CALIBRATED. THE MICROSENSOR WAS SYNCHRONIZED TO THE PHILIPS BEDSIDE MONITOR. AFTER 24 HOURS, THE CURVE/WAVE BECAME ¿WEIRD¿ AND WAS NOT GIVING FAITHFUL INFORMATION COMPARED WITH OTHER CLINICAL DATA. THE FACILITY DEFINED ¿WEIRD¿ AS: ¿AN UNUSUAL IMAGE OF THE CURVE, LIKE NO BRAIN ACTIVITY, OR LOW BRAN ACTIVITY. WHILE THE PATIENT SITUATION WAS COMPLETELY DIFFERENT, ACCORDING TO CLINICAL DATA.¿ THE FACILITY CARRIED OUT EVERY STEP BEFORE CONSIDERING THAT THE MICROSENSOR WASN`T WORKING. THE MICROSENSOR WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH A NEW MICROSENSOR THAT WORKED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146883 MICROSENSOR KIT W/ SKULL BOLT ICP MICROSENSORS GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 4143348

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown