MAUDE Adverse Event Report: PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX442T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant a progav had a dysfunction postoperatively; the adjustment would spontaneously change.The patient was originally implanted on (b)(6) 2016.The valve was explanted on (b)(6) 2017 and returned to the manufacturer for evaluation.Further details were not provided.Height: 130 cm.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Manufacturing and quality control data the progav was manufactured by a qualified employee in january 2016.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav has a normal pressure range of 0 to 20 cmh2o.The valve was inspected as article fx442t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Investigation statement: on the basis of juristic requirements we have to get the personal request by the surgeon as a step of safeguard.Unfortunately we did not receive the consent.An official release is missing for the investigation of the product.For this reason, we returned the product for our discharge without examination.Result: we can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further actions required.

• Brand Name: PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• MDR Report Key: 12752497
• Report Number: 3004721439-2021-00709
• Device Sequence Number: 16520933
• Product Code: JXG
• UDI-Device Identifier: 04041906137472
• UDI-Public: 4041906137472
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: FX442T
• Device Catalogue Number: FX442T
• Device Lot Number: 20029033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 YR
• Patient Weight: 30