MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem High impedance (1291)

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

Event Date 01/05/2015

Event Type  malfunction  

Event Description

It was reported that during generator and lead replacement surgery on (b)(6) 2015 due to high impedance, the septum plug from the vns patient¿s replacement device popped out while removing the hex screw driver after tightening the setscrew.It was noted that the surgeon is very experienced and careful.Another generator was used to complete the procedure.The explanting facility will not return the device to the manufacturer for analysis; therefore, no analysis can be performed.The high impedance event was reported in manufacturer report # 1644487-2014-03035.

Event Description

The generator with the detached septum plug was returned to the manufacturer for analysis.No signs of manipulation of the returned setscrew were present.The septa meet specification requirements.The header septum cavity meets specification requirements.Therefore, a root cause for the event could not be determined.

Manufacturer Narrative

Manufacturer Narrative

(b)(4).Additional manufacturer narrative and/or corrected data; corrected data: the initial mdr inadvertently did not include the suspect device udi.This report is being submitted to correct this data.

• Brand Name: PULSE GEN MODEL 105
• 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: 4460754
• MDR Text Key: 5187525
• Report Number: 1644487-2015-03703
• 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,Followup
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: 105
• Device Lot Number: 4033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2014
• 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: 20 YR