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

Model Number	823148
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Headache (1880)
Date of Event	11/24/2022
Type of Reportable Event	Serious Injury
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 facility reported a hakim valve (id 823148) was implanted in a 16 year-old patient via vp shunt on (b)(6) 2022 with an initial set pressure of 110 crossed checked through x-ray.On (b)(6) 2022, patient came back deteriorated with symptoms cerebrospinal fluid (csf) over drainage (headache and altered sensorium) and pressure was automatically changed to 70.The physician changed the pressure to 110 and was discharged.On (b)(6), the patient was admitted again with deterioration and valve pressure changed again to 70.The valve was removed and replaced on (b)(6), 2022.The patient condition improved.
Additional Manufacturer Narrative
The hakim valve (id823148 ) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The cause(s) of the difficulty reported by the customer could not be determined.However, a probable root cause for the reported complaint is due to set pressure of valve changes due to external forces (not surgeon interaction).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 or Problem Description
N/a.

• 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: 15971897
• Report Number: 3013886523-2022-00570
• Device Sequence Number: 12326783
• Product Code: JXG
• UDI-Device Identifier: 10381780519225
• UDI-Public: (01)10381780519225
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 823148
• Device Catalogue Number: 823148
• Device Lot Number: 6169213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 03/16/2023
• Date Device Manufactured: 02/10/2022
• 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: 16 YR
• Patient Sex: Male