MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR NEUROMONITOR BASIC KIT; ICP MICROSENSORS

Model Number	82-6631
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The microsensor was not returned for evaluation; however, pictures were provided and evaluated: it was not possible to investigate the complaint as the device has been discarded.Therefore, with the pictures provided, we can confirm that the device was damaged, and has shell peeled off.The possible root cause of the damage observed on the pictures could be probably due to a mishandling, as noted in the ifu of the product the device 826631 must be used with care to avoid any damage.
Event or Problem Description
A physician reported that after unpacking the microsensor, it was found that shell was peeled off but it could be zeroed normally and could show normal reading.The microsensor was implanted to the patient and was monitored during the procedure.However, after the monitoring the microsensor was discarded.There were no delays and no adverse consequences to the patient.

• Brand Name: NEUROMONITOR BASIC KIT
• Common Device Name: ICP MICROSENSORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12104951
• Report Number: 3013886523-2021-00276
• Device Sequence Number: 4601314
• Product Code: GWM
• UDI-Device Identifier: 20886704042317
• UDI-Public: (01)20886704042317(17)241130(10)4318456
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 82-6631
• Device Catalogue Number: 826631
• Device Lot Number: 4318456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1