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

Catalog Number 823101

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

Patient Problem Injury (2348)

Event Date 12/15/2020

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 a hakim valve was implanted via v-p shunt due to congenital hydrocephalus (unknown date and setting) and patient had a postoperative infection.On (b)(6) 2020, the valve was removed except the ventricular catheter.However the physician commented that the valve is not related to the infection.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The valve was returned for evaluation: review of the history device records for lot cvfctf, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected, a needle hole was noted in the silicone housing.The position of the cam when valve was received was 30mmh2o.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the silicone housing.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.No root cause was determined for the infection issue, as noted in additional information: the physician commented that the valve is not related to infection.

• 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: 11120858
• MDR Text Key: 225280564
• Report Number: 3013886523-2020-00298
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 823101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1