MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problems Leak/Splash (1354); Device Inoperable (1663); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/15/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to end of service.Prior to replacement, the surgeon stated that some sort of silicone based substance was leaking from the generator.The substance was described as white in color, and the surgeon believed that it was an inorganic-based substance.A sample of this was sent to the pathology lab at the hospital for analysis.No results of the pathology lab¿s analysis have been received to date.The generator was explanted and returned to the manufacturer where analysis is currently underway.

Event Description

Analysis of the generator was completed on 10/31/2014.Residue was observed on the pulse generator feed-thru assembly and is known to be related to the manufacturing process of the component.There was evidence of body fluid remnants on the case exterior.The septum was cored, but no evidence of dried fluids was found in the septum cavity.No leaking white substance was observed on the pulse generator.The module performed according to functional specifications.There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.The final pathology results indicate soft tissues, left side of chest, organized fat necrosis.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 4157456
• MDR Text Key: 4765966
• Report Number: 1644487-2014-02614
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2011
• Device Model Number: 102
• Device Lot Number: 2555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR