MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CHPV RT ANG RESERVOIR UNITIZED

Model Number	823148
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A physician reported a hakim valve (id 823148) was implanted and had programming difficulties and leakage.The issue was noted after 10 days from surgery while the patient was admitted with worsening symptoms.At the time of this report the valve remains implanted; however, a revision surgery is planned.No additional information has been provided after several attempts.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve (id: 823148) was not returned for evaluation (revision surgery was planned; it is unknown if valve was explanted, no additional information was received after several attempts) ; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.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.

• Brand Name: CHPV RT ANG RESERVOIR UNITIZED
• Common Device Name: CHPV
• 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: 14083999
• Report Number: 3013886523-2022-00144
• Device Sequence Number: 5317753
• Product Code: JXG
• UDI-Device Identifier: 10381780519225
• UDI-Public: (01)10381780519225(17)261031(10)5950893
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 823148
• Device Catalogue Number: 823148
• Device Lot Number: 5950893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/25/2022
• Date Device Manufactured: 11/05/2021
• 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: 42 YR
• Patient Sex: Male