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

Catalog Number 823101

Device Problem No Flow (2991)

Patient Problem Headache (1880)

Event Date 03/09/2021

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 that a medos programmable infant valve system was implanted to a (b)(6) year-old female patient via v-p shunt to treat sah (subarachnoid hemorrhage) in 2018 with an unknown setting.At the end of (b)(6) 2021, the patient visited the hospital due to headache and the pressure setting was changed; however patient's symptoms did not improve.Contrast was perfomed and outflow of contrast to the abdominal cavity could not be confirmed.The valve was removed and replced on (b)(6) 2021.No further information was provided by the hospial.

Event Description

N/a.

Manufacturer Narrative

The valve was returned for evaluation: device history record- lot crkcmy, 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 70mmh2o.The valve passed the test for programming, flushing, leaking, reflux and pressure.The catheter was irrigated, no occlusions noted.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.No occlusion was noted during the investigation of the valve.

• 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: 11599697
• MDR Text Key: 243281839
• Report Number: 3013886523-2021-00145
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 823101
• Device Lot Number: CRKCMY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR