MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS RA SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Catalog Number 828824

Device Problem Infusion or Flow Problem (2964)

Patient Problems Headache (1880); Hearing Impairment (1881); Dizziness (2194)

Event Type  Injury  

Manufacturer Narrative

The certas valve (id 828824) was not returned for evaluation (remains implanted) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.The possible root cause for the issue reported by the customer could be due to biological debris and protein buildup interfering with the valve mechanism.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 Description

This is 2 of 4 reports linked to mfg report numbers: 3013886523-2022-00033; 3013886523-2022-00035; 3013886523-2022-00036.A physician reported four patients had hearing loss ((b)(6) and older) following certas valve implantation.Original setting was 3 in all four cases to match the medtronics strata ii 1.5 setting that the surgeon uses.According to physician: "this is what the documentation suggests (the certas 3 is equivalent to strata 1.5)".Patients came back to the hospital one to two weeks after implantation with overdrainage symptoms; hearing loss, headaches and dizziness.Setting was changed to higher opening pressure setting in the clinical follow-ups in weeks after.The valve was changed to setting 8 to virtually close it.Implantation date is unknown.Valves remain implanted /they were turned off.Additional information has been requested to the physician to provide clarity or documentation pointing to medtronic strata setting 1.5 being equivalent to the certas setting 3, and documentation has not been provided.

• Brand Name: CRTS RA SG VLV ONLY
• Type of Device: CERTAS PLUS SMALL & RA W/SG
• 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: 13509294
• MDR Text Key: 289487520
• Report Number: 3013886523-2022-00034
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1