MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICROSENSOR KIT W/ SKULL BOLT; ICP MICROSENSORS

Catalog Number 826638

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2023

Event Type  Injury  

Event Description

A physician reported that after doing step by step the calibration of the microsensor with the directlink, it was not possible to achieve a curve and number in the bedside monitor, only a question mark appears.They recalibrate the microsensor following the instructions without obtaining results, therefore, the sensor was explanted.The event led to 4 hours delay in the procedure, however, no anesthesia was involved as the patient was already sedated and intubated in the icu.

Manufacturer Narrative

Microsensor (id 826638) was not returned for evaluation due to biological contamination; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.However, the possible root cause for this issue reported by the customer could be due to a user error.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: MICROSENSOR KIT W/ SKULL BOLT
• Type of Device: ICP MICROSENSORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18192903
• MDR Text Key: 328814121
• Report Number: 3013886523-2023-00400
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10381780520504
• UDI-Public: (01)10381780520504(17)270831(10)6694033
• Combination Product (y/n): N
• PMA/PMN Number: K914479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 826638
• Device Lot Number: 6694033
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2023
• Date Device Manufactured: 09/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DIRECT LINK (ID 826828); PHILLIPS MONITOR INTERFACE CABLE (ID 826881)
• Patient Sex: Male
• Patient Race: White