MAUDE Adverse Event Report: RAYNHAM HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number XXX-HAKIM PROGRAMMABLE VALVE

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 05/13/2021

Event Type  Injury  

Manufacturer Narrative

The hakim valve was not returned for evaluation (remains implanted) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer 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.

Event Description

A physician reported that a hakim programmable valve was implanted in a patient 23 years ago via a ventricular peritoneal shunt with an unknown initial setting.A few months later after the implantation, a second shunt (¿823100 estimated¿) was implanted in the patient due to infection.The patient is now (b)(6) and now presented with 2 valves implanted.On (b)(6) 2021, an mri was performed, when the physician tried to adjust the pressure, ¿the cam moved like a jump during the x-rays¿.It was reported that it was presumed the cam had fallen off and made a dance-like movement in the prechamber.It is unknown which valve the cam dropout occurred.No adverse consequences to the patient were observed.Since it seems that the shunt system is no longer needed, there are currently no additional procedures scheduled such as reoperation.The device was not removed.The patient is currently in follow-up.No further information was provided by hospital.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 11983871
• MDR Text Key: 255746049
• Report Number: 3013886523-2021-00268
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00886704071099
• UDI-Public: 0886704071099
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-HAKIM PROGRAMMABLE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2021
• 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
• Patient Age: 23 YR