MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE RIGHT ANGLE; CHPV

Catalog Number 823184

Device Problem Infusion or Flow Problem (2964)

Patient Problem Brain Injury (2219)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

The patient was diagnosed with hydrocephalus in or about (b)(6) 2018.After going over various options, his medical team recommended surgery and the insertion of a shunt to drain fluid from his head.The surgery took place on (b)(6) 2019.The procedure took approximately 2 hours, during which the medtronic shunt and codman hakim programmable valve were inserted in accordance with standard practice and procedure.The surgery was completed at approximately 11:20 a.M.While in post-op care, at approximately 6 p.M., patient became lethargic and lost consciousness.He was subsequently taken for a ct scan where it was discovered that the shunt was draining fluid far too rapidly.As a result, he was rushed into a further surgery where the shunt was clamped off to prevent further drainage, however, that was not before patient suffered what appears to be significant brain damage including, but not limited to an inability to walk, paralysis of his vocal chords, an inability to eat among other things.

Manufacturer Narrative

Complaint sample was not returned for evaluation therefore; an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.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.- manufacturing date for the lot 3303262 is november 27th, 2018 and the expiration date is october 31st, 2023.- udi (b)(4).Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(4) office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: PROG VALVE RIGHT ANGLE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10277996
• MDR Text Key: 202700997
• Report Number: 1226348-2020-00055
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K041296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823184
• Device Lot Number: 3303262
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR