MAUDE Adverse Event Report: CHRISTOPH MEITHKE GMBH & CO PROSA VALVE

Model Number FV701T

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Valve has been implanted in (b)(6) 2013.It was adjustable and readable until (b)(6) 2013.Now it is not readable anymore and the doctor just got the info "unused range".The valve had to be explanted.

Manufacturer Narrative

Us reporting agent notified on (b)(6) 2014.Manufacturing site evaluation: all parameters of the valve were inspected and passed prior to its release.The investigations of the valve resulted in the failure of the control function.The body of the valve is deformed.This deformation causes the lowering of the housing membrane, resulting in failure of brake function.Damage to the valve is of unknown origin, however, this type of damage is generally related to excessive pressure while using adjustment tool.

• Brand Name: PROSA VALVE
• Manufacturer (Section D): CHRISTOPH MEITHKE GMBH & CO; postdam, de 1446 9
• Manufacturer (Section G): CHRISTOPH MEITHKE GMBH & CO; 2 ulanenweg; postdam, de 1446 9
• Manufacturer Contact: michelle link ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3883082
• MDR Text Key: 4426261
• Report Number: 2916714-2014-00101
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K120559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/25/2013
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other