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

Model Number 105

Device Problems Electromagnetic Interference (1194); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

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

Event Date 10/22/2014

Event Type  malfunction  

Event Description

It was reported that during initial implant surgery, the device diagnostics were run with the generator in the pocket and resulted in vbat less than eos.It was reported that two device diagnostics performed prior to closing the generator pocket were within normal limits, but that after the generator pocket was closed the vbat less than eos message appeared.It was reported that the generator was likely exposed to electrocautery during the surgery.The surgeon replaced then replaced the generator.The explanted generator was received for analysis.Analysis is underway, but has not been completed to date.

Manufacturer Narrative

(b)(4).Corrected data: inadvertently did not include the udi on the initial report.

Event Description

Analysis of the returned generator was completed which confirmed an output pulse disabled condition due to a perceived low battery voltage.Analysis concluded that the event may be related to high energy exposure during surgery.The pulse generator performed according to functional specifications after output was re-enabled.

• 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: 4255773
• MDR Text Key: 5017074
• Report Number: 1644487-2014-03039
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2014

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: Lay User/Patient
• Device Expiration Date: 08/08/2016
• Device Model Number: 105
• Device Lot Number: 4033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 11/17/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/29/2014; 04/21/2015
• 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