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

Model Number 105

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 11/28/2014

Event Type  malfunction  

Event Description

During generator replacement surgery, it was reported that this replacement generator was not used because it ¿did not work.¿ additional information was received that an error message of ¿checksum error¿ was received on the vns programming system when communicating with the generator.This error message is a communication issue message.The surgeon elected to discard the generator and discard it due to the check sum error message.After the wand 9v battery was replaced, the programming system worked as intended.However, the wand battery was not replaced until after the generator was discarded.Following the replacement of the wand battery, a new generator was placed and interrogated successfully.The generator was received by the manufacturer for analysis.However, analysis has not been completed to date.

Event Description

The reported allegation was not duplicated in the pa lab.The pulse generator was interrogated at multiple orientations adjacent to the programming wand.The pulse generator was at a distance of one-inch (spacer block) from the programming wand during the interrogations.The pulse generator interrogated at all orientations.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery shows an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Manufacturer Narrative

(b)(4).

• 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: 4343403
• MDR Text Key: 5140522
• Report Number: 1644487-2014-03404
• 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: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: 105
• Device Lot Number: 4082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/19/2015; 04/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2014
• 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: 24 YR