MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number 823100

Device Problem Positioning Problem (3009)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported they were unable to adjust the settings on a hakim programmable valve.The valve was initially implanted in a patient on (b)(6) 2020.The initial setting was unknown.The provider was not able to change the setting and the patient required a revision surgery on (b)(6) 2020 to replace the valve.No patient's signs and symptoms reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d4, d10, g4, g7, h2, h3, h4, h6, h10.Unique device identification (udi): (b)(4).The hakim valve was not returned therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.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.¿.

Manufacturer Narrative

(b)(4).The hakim valve was returned for evaluation.Device history record - there is no indication that the production process may have contributed to this complaint.Failure analysis - the valve was visually inspected; biological debris was noted on the spring.The valve failed the test for programming, the cam mechanism did not move during the programming process.The valve passes the test for occlusion, leak, reflux and pressure.The root cause for the programming issue reported by the customer was due to biological debris found on the spring, on the ruby ball, on the seat of the ruby ball, on the cam mechanism and on the base plate.

Event Description

N/a.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10293013
• MDR Text Key: 202704027
• Report Number: 1226348-2020-00449
• 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,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823100
• Device Lot Number: 3841179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1