MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES IMPLANTS (FRANCE) S.A.S HORIZONTAL/ VERTICAL LUMBAR VALVE SYSTEM; LUMBOPERITONEAL SHUNT

Model Number 903345A

Device Problems Material Fragmentation (1261); Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2017

Event Type  malfunction  

Event Description

Three separate lumboperitoneal shunt system were opened due to defective implants.Catheter was tearing easily while dr (b)(6) was attempting to place the shunt.None of the implants were expired.Md requests that implants be further investigated.Two systems noted above were wasted.Patient came back at a later date and had removal of ventriculo peritoneal shunt and lp shunt, dr (b)(6) laparoscopic assisted lumboperitoneal shunt placement.Patient came back at a later date and had removal of ventriculo peritoneal shunt and lp shunt, dr (b)(6) laparoscopic assisted lumboperitoneal shunt placement.Cross reference medwatch report numbers 2023988-2018-00026 and 2023988-2018-00027.Additional information has been requested.

Manufacturer Narrative

Several attempts were made to obtain additional additional information was not received.(b)(6) 2018, request for additional information.(b)(6) 2018, request for additional information.Natus completed their investigation on(b)(6) 2018, the investigation included the following methods: review of device history and service records review of past capas/ capa determination.Review of complaints history and complaint rate.The customer's complaint "no icp reading values" could not be confirmed as the customer has not returned the device for evaluation.Dhr review: the dhr was reviewed and no anomalies that could be associated with the complaint incident were observed.Batch history record shows the cam02, no.1 150402532 met requirements.The device was manufactured on: 2015-04 (cam02).Capa: n/a - no capa was issued from the last 24 months.Complaint history review/ trend analysis: there was one (1) other complaints that similar reporting integ-functional fit and it was confirmed from (b)(6) 2016 through (b)(6) 2018, divided by the number of camcabl sold, (707 and multiplied by 100 results in a failure rate percentage 0.141% risk management: a review of the cam02 medical device hazard analysis identifies the hazard for the customer's complaint."monitor not functional prior to use" (hazard id#dla-007).The harm being an "inconvenience to user" with a severity of negligible.Root cause: n/a - device not returned for evaluation.Did the device likely contribute to reported incident or adverse event? unable to determine.This complaint is now deemed closed.

• Brand Name: HORIZONTAL/ VERTICAL LUMBAR VALVE SYSTEM
• Type of Device: LUMBOPERITONEAL SHUNT
• Manufacturer (Section D): INTEGRA NEUROSCIENCES IMPLANTS (FRANCE) S.A.S; 2905 route des dolines; sophia antipolis 06560 ; FR 06560
• MDR Report Key: 7561554
• MDR Text Key: 110344807
• Report Number: 2023988-2018-00028
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780035404
• UDI-Public: 10381780035404
• Combination Product (y/n): N
• PMA/PMN Number: K161992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Model Number: 903345A
• Device Catalogue Number: 903345A
• Device Lot Number: 0188292
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention