MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MEDOS PROG INFANT VALVESYSTEM; CHPV

Catalog Number 823101

Device Problem Pressure Problem (3012)

Patient Problem Failure of Implant (1924)

Event Date 07/15/2021

Event Type  Injury  

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 Description

A physician reported the hakim valve was implanted to the patient via v-p shunt on (b)(6)2020 with an unknown setting.The setting was originally 190mm2o however, the setting was changed to 30mm2o that became an over drainage tendency.The physician tried to increase the set pressure and could not get it changed.The valve was replaced on (b)(6) 2021.The patient is in follow up status.

Manufacturer Narrative

The hakim valve was returned for evaluation.Device history record (dhr) - the product code 82 3101 with lot 3857141, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; no defects were noted.The position of the cam when valve was received was 140mmh2o.The valve was hydrated.The catheters were irrigated no occlusions noted.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation functional issues were noted.

Event Description

N/a.

• Brand Name: MEDOS PROG INFANT VALVESYSTEM
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12289091
• MDR Text Key: 265428838
• Report Number: 3013886523-2021-00357
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 823101
• Device Lot Number: 3857141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1