MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE; CHPV

Catalog Number	823164
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Vomiting (2144); Dizziness (2194); Decreased Appetite (4569)
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
This is 1 of 2 reports linked to mfg report number: 3013886523-2024-00195.It was reported that on (b)(6) 2024, a hakim valve (id (b)(6)) and bactiseal catheter (id (b)(6)) were implanted to treat nph (normal pressure hydrocephalus).The physician reported that on an unknown date, for last one week the patient is showing abnormal behavior/not a normal behavior (abnormal behavior), the initial issues have started like untimely vomiting, lack of appetite (decreased appetite), weakness (asthenia) and dizziness and others, similar issues started last time which required the patient to be admitted in hospital later.Additionally, reporter stated that patient is implanted with programmable device, it has been 4 months plus and he feels that the initial pressure setting that was done at the time of operation/implantation has changed and he wanted to get the current pressure of the device tested and readjusted to optimum level in order to make sure the patient is not pushed to any bad situation.If the pressure of the implanted device is not adjusted to the suitable level immediately then the patient will slowly go back to the same state where she was before implantation of device.The causality for the reported events is considered as not assessable for the suspect drug due to limited information regarding therapy details of the suspect drug, onset date and outcome of the reported events, concomitant medication, and lab data.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve (id (b)(6)) was not returned for evaluation: as per customer, the product remains implanted; 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.
Additional Manufacturer Narrative
Additional information received: follow-up information was received from a physician: "additionally informed that the patient was showing abnormalities for almost last 10 days and it was getting worsened." "added additional event as condition aggravated.Post implantation patient improved a lot for his condition but in recent past, patient had developed few symptoms.".
Event or Problem Description
N/a.

• Brand Name: PROG VALVE INLINE
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19680242
• Report Number: 3013886523-2024-00194
• Device Sequence Number: 15166529
• Product Code: JXG
• UDI-Device Identifier: 10381780519249
• UDI-Public: (01)10381780519249(17)280229(10)7105261
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2024

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 Catalogue Number: 823164
• Device Lot Number: 7105261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 10/16/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 08/20/2024; 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BACTISEAL CATHETER (ID (B)(6)).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Female