MAUDE Adverse Event Report: RAYNHAM HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number XXX-HAKIM PROGRAMMABLE VALVE

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Headache (1880); Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.(b)(4).

Event Description

2 of 2 reports: other mfg report number: 3013886523-2021-00028.J neurosurg 112 (2010) published."overdrainage of cerebrospinal fluid caused by detachment of the pressure control cam in a programmable valve after 3-tesla magnetic resonance imaging" the authors report a rare case of overdrainage of the csf caused by the malfunction of a codman-hakim programmable valve (chpv) following a 3-t mr imaging procedure.Adverse events: postural headache, neck pain, nausea, case report: in 2001 a (b)(6) year-old woman underwent ventriculoperitoneal shunt placement with a chpv system for hydrocephalus due to subarachnoid hemorrhage.Her postoperative course was uneventful and she had no neurological deficits.Postoperative radiography confirmed normal structure of the valve system.A radiograph of the skull obtained after 1.5-t mr imaging 5 years ago showed detachment of the white marker of the chpv.Because the patient had no complaints and the function of the shunt system was judged to be intact, she was monitored without additional treatment.A radiograph obtained after 1.5-t lumbar mr imaging at another hospital 1 month before presentation to our center showed that the status of the valve had not changed.Examination.Detachment of the complex pressure control cam in the chpv system was revealed on radiography studies performed after a 3-t lumbar mr imaging procedure at our hospital.The patient experienced postural headache, neck pain, and nausea several hours after the mr imaging study.She had incurred no head injury that day, and she remembered suffering no head injury in the past few months.Because of continued symptoms, ct scanning was performed and revealed a slight decrease in ventricle size.Treatment and posttreatment course.Revision of the chpv system promptly resolved the patient¿s symptoms, and a postoperative ct scan revealed normalization of the ventricle size.The manufacturer, medos s.A., analyzed the extracted valve in detail.They reported that the complex pressure control cam, cross-shaped base piece and stepper motor, and white marker were detached from the base plate.A y-shaped crack was observed in the plastic housing over the flat spring.The construction of the pressure control cam, including the cam, shaft, and position indicator, did not appear to be damaged.(doi: 10.3171/2008.3.17688).

Event Description

N/a.

Manufacturer Narrative

The hakim valve was not returned for evaluation 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.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11174382
• MDR Text Key: 233587211
• Report Number: 3013886523-2021-00029
• Device Sequence Number: 1
• Product Code: JXG
• 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
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• 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
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR