MAUDE Adverse Event Report: RAYNHAM HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number XXX-HAKIM PROGRAMMABLE VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

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 a codman hakim programmable valve was implanted in a patient on an unknown date.It was reported probable shunt infection; however, the patient¿s signs and symptoms of a possible infection were not provided and no laboratory testing was provided.The shunt valve is still implanted in the patient and no further information is available.The physician did not schedule the patient for shunt removal at this time.

Manufacturer Narrative

Additional information received: "the valve was implanted to the patient about 2 month ago with unknown setting.It was used with bactiseal(serial:unk).The patient had pneumonia / urinary tract infection before the implant, but after it had subsided, surgery was performed.Infectious symptoms such as fever developed 3 weeks after surgery and a cerebrospinal fluid test shows that the protein has increased, but the number of cells has not increased.Hematoma remains in the ventricles of patient with intraventricular hemorrhage.Implantation of a shunt resulted in overdrainage and was likely to result in subdural hematoma.According to the doctor, it is not determined that it is a shunt infection.".

Event Description

N/a.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 11819015
• MDR Text Key: 250429598
• Report Number: 3013886523-2021-00220
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• 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: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1