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

Catalog Number 823184

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Headache (1880); Loss of Vision (2139)

Event Date 04/12/2019

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

Medwatch report # mw5090406.Patient reported the following: ¿i had a codman hakim programmable valve right angle product code 82-3184, lot 213912.Since (b)(6), my surgeon has not been able to set the valve with verification.I have disabling headaches and vision lost.My surgeon says after he tries to set the valve, he cannot get a feedback verification and he is using a skull x-ray to verify the valve setting.Codman in part recalled its certa model over a handful of cases wherein the surgeons could not get a feedback to verify the setting.¿ additional information received form the patient on december 11, 2019: action taken to resolve the issue: ¿while i cannot attribute it to the shunt, since (b)(6) i have had endless appointments to set the valve.Something happened to cause him to change the setting from 90 to 200.About two months later he brought me in because of all the problems i was having and changed it to 160, then about 6 weeks later to 120, and then two weeks ago he changed it back to 90.Each setting was verified by the skull x-ray.¿ ¿i remain with headaches and balance problems.The shunt placement does hurt.But my vision has increased significantly.Also, i have hypothalamic dysfunction.According to the nih shunting can restore the hypothalamus.For years i have been on a double dosage of androgel to sustain me in the 300's.I am not just under 900, and i have been changed from 4 pumps to 3, and in about 3 weeks will be changed to see 2 pumps if i remain in the high side of normal.My point is the shunting seems to have helped the function of the hypothalamus.¿ ¿surgeon mentioned replacing it with a newer model, but for now wants to continue to try more adjustments.I see him in (b)(6) after a brain ct scan.He wants to make sure it is not over draining.¿ ¿for now, i live with the mild headaches and balance problems.¿.

Manufacturer Narrative

Additional information received from the patient: "i think it was about 6 weeks after the april 2019 surgery the headaches started.Remember during the surgery the physician drained a lot of cerebral fluid.Initially when i reported the problems, the physician prescribed steroids.The main reason i think the problem is the shunt is there has been improvement.Nih has reported restoration of the hypothalamus after shunting.My testosterone levels have increased significantly and i am not being pulled off of the androgel.The physician has been making adjustments to the value about every 6 weeks.Because he cannot verify the setting he sends me for skull x-rays which allow him to see the valve setting.I am due to return to him on (b)(6) 2020.He will have a ct scan done to insure it is not over draining.My setting is currently at 90.The skull x-ray verifies the setting.The area of the shunt is sore at times, and even red.I suffer from a mild headache at the time.The 90 setting helped a lot.My pcp has ruled out any sinus infection as a contributing factor.But it seems to me he should be able to get a read back verifying the setting and he cannot.He has the newest device for doing this and he cannot get a read back.So obviously something is wrong and this will be an issue for the remainder of my life.In the event of an emergency mri because the doctor is 4 1/2 hours away another brain surgeon may not be comfortable verifying the setting with a skull x-ray." 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.

Event Description

N/a.

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.Between (b)(6)2019 and (b)(6)2020, 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 (b)(6)2019 through (b)(6)2020.Integra lifesciences contacted donna engleman, director of regulatory programs, office of product evaluation and quality and michelle rios, assistant director, mdr team, office of product evaluation and quality on (b)(6)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: 10277009
• MDR Text Key: 204071742
• Report Number: 1226348-2019-00614
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2019

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: 213912
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOSARTAN 50 MG; ZETIA 10 MG