MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE VALVE 120CM; CERTAS PLUS W/ BACTISEAL

Catalog Number	828803PL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Nausea (1970); Dizziness (2194)
Type of Reportable Event	Serious Injury
Event or Problem Description
This is linked to mfg report numbers: 3013886523-2023-00189.3013886523-2024-00015.A patient reported a certas valve was implanted on (b)(6) 2023.On (b)(6) 2023, shunt was set at 5.On (b)(6) 2023, the shunt was checked at 4, and was set again to 5.On (b)(6) 2023, the shunt was checked, and found at 4 again, then set to 6.On (b)(6)2023, the shunt was checked and found at 2, therefore it was set to 5 again.On (b)(6) 2023, a new shunt was placed, and was set on 4.The patient is currently fine when sitting or resting.However, still dizzy and nauseated when getting up.The first shunt was placed on (b)(6) 2023 which was found to be defective.The second shunt was placed on (b)(6) 2023 and was also defective.The third shunt was placed on (b)(6) 2023 with setting 4.There is currently no complaint for the third shunt.The patient was fine when sitting or resting; however, she experienced dizziness and nausea when getting up.
Additional Manufacturer Narrative
The certas valve was not returned for evaluation 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.No root cause needed as: ¿there is currently no complaint for the third shunt placed on (b)(6) 2023¿.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.
Additional Manufacturer Narrative
Dhr - lot 7174255, conformed to the specifications when released to stock.Additional information received: (brief operative note) name: (b)(6) is a 60 years old.Female.Ob: (b)(6) 1962.Date of operation: (b)(6) 2023.Preoperative diagnosis: vp (ventriculoperitoneal) shunt status, obstructive hydrocephalus post-op diagnosis: vp (ventriculoperitoneal) shunt status, obstructive hydrocephalus procedure(s) (lrb): replacement/revision cerebrospinal fluid shunt system - ventriculoperitoneal (right) findings: functioning proximal catheter, replaced valve and distal catheter.Estimated blood loss: no blood loss documented.Specimen(s) removed/disposition: no specimens in log complications: none0 disposition: icu - stable.

• Brand Name: CERTAS PLUS INLINE VALVE 120CM
• Common Device Name: CERTAS PLUS W/ BACTISEAL
• 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: 18664026
• Report Number: 3013886523-2024-00028
• Device Sequence Number: 7317146
• Product Code: JXG
• UDI-Device Identifier: 10381780521136
• UDI-Public: (01)10381780521136(17)240430(10)7174255
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 828803PL
• Device Lot Number: 7174255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female