MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED DBA INTEGRA NEUROSCIENC MICRO VENTRICULAR BOLT PRESSURE MONITORING KIT; INTRACRANIAL PRESSURE MONITORING DEVICE

Model Number	110-4HM
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
From complaint initiation form received 31 oct 2017: "a clinician with natus received a call from the dr.(b)(6).He placed a 110-4hm catheter on (b)(6) 2017.On day 5 ((b)(6) 2017) he noticed a 10 degree increase in icp from the manual readings.He will try to save the catheter to send in for evaluation"."device in contact with patient: yes"."patient injury / death alleged: no"."revision/medical intervention required: no".Patient prepped for surgery: no"."delay in surgery due to late receipt of product: no"."delay in surgery due to product problem: no"."out of box failure(oob): no".
Additional Manufacturer Narrative
Received 13 dec 2017 from natus clinical specialist: "hello - the facility did not report to the fda.I do not have information on the patient's weight".The device has yet to be returned.A request is being made to obtain its return.Natus has completed their initial internal investigation on 04 dec 2017.The investigation included: methods: review of past complaints from facility, capa review, complaint history review/trend analysis.There were (b)(4) other 110-4xxx complaints reported from (b)(6) medical since dec-2015.No complaints were confirmed.A review of capas within the past 12 months specific to this customer's complaint under investigation found no capa related to this reported catheter complaint.Complaint history, model 110-4xxx, from nov-2015 through 27-nov-2017 reviewed; there were (b)(4) other complaints that issued with complaint code (b)(4), and one of them confirmed.The number of confirmed reports (01) divided by the number of units sold model 110-4xxx, ((b)(4)), nov-2015 through oct-2017 and multiplied by 100 results in a failure rate percentage (b)(4).
Additional Manufacturer Narrative
Added 08 feb 2018: on 24 dec 2017, a natus clinical specialist e-mailed that the prior account representative for integra did not pick-up the sample (if it had been held at the user facility) and that it may have not been sent in.On 22 jan 2018, natus called dr.(b)(6) office.A message was left inquiring if the catheter could be saved.As of 08 feb 2018, no response has been received in regards to the catheter.The complaint is considered closed as non-returning.The complaint could not be confirmed and no investigation results other than those reported on (mdr) follow-up 1 are possible since no l/n was reported.

• Brand Name: MICRO VENTRICULAR BOLT PRESSURE MONITORING KIT
• Common Device Name: INTRACRANIAL PRESSURE MONITORING DEVICE
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED DBA INTEGRA NEUROSCIENC; 5955 pacific center blvd.; san diego CA 92121
• MDR Report Key: 7069633
• Report Number: 2023988-2017-00509
• Device Sequence Number: 16586795
• Product Code: GWM
• UDI-Device Identifier: 10381780258049
• UDI-Public: 10381780258049
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K914735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2017

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: Physician
• Device Model Number: 110-4HM
• Device Catalogue Number: 110-4HM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 12/14/2017; 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR