MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PRESSURE OUTPUT CABLE- PHILIPS; DIRECTLINK - CABLES

Model Number	82-6881
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint sample was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer 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.
Event or Problem Description
Linked to mfg report numbers: 3013886523-2022-00538, 3013886523-2022-00539, 3013886523-2022-00540, 3013886523-2022-00541 and 3013886523-2022-00542.A facility reported the icp readings of a microsensor were stable 2-3 hours after implantation.But after that, the value kept drifting down until it was in the negative range at some point.4 cerelink icp sensor with metal skull pin set were implanted, 2 different directlink modules were used.All cables were swapped and different patient monitors connected.The error kept appearing.According to reported information, it is unknown if there was patient injury and it is also unknown if there was surgical delay.

• Brand Name: PRESSURE OUTPUT CABLE- PHILIPS
• Common Device Name: DIRECTLINK - CABLES
• 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 ; 6099362319
• MDR Report Key: 16409553
• Report Number: 3013886523-2023-00046
• Device Sequence Number: 17550917
• Product Code: GWM
• UDI-Device Identifier: 10886704075714
• UDI-Public: 10886704075714
• Combination Product (Y/N): N
• PMA/510(K) Number: K152670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2023

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 Model Number: 82-6881
• Device Catalogue Number: 826881
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown