MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICROSENSOR VENTRICULAR CATHETER KIT; ICP MICROSENSORS (ROHS)

Catalog Number	826653
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported a microsensor (826653) was implanted on (b)(6) 2023.On (b)(6) 2023 the icp monitor showed no readings, therefore, the microsensor was replaced.Based on the information provided, the patient did not experienced any signs and symptoms.The sensor was used with the icp monitor (826635) and icp cable (826636).
Additional Manufacturer Narrative
The microsensor (id 826653) was not returned for evaluation; 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.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 VENTRICULAR CATHETER KIT
• Common Device Name: ICP MICROSENSORS (ROHS)
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 17673256
• Report Number: 3014334038-2023-00143
• Device Sequence Number: 6057194
• Product Code: GWM
• UDI-Device Identifier: 10381780520566
• UDI-Public: 10381780520566
• Combination Product (Y/N): N
• PMA/510(K) Number: K991222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 826653
• Device Lot Number: 6620984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ICP CABLE (826636); ICP MONITOR (826635)
• Patient Sex: Unknown