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

Model Number 105

Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 04/30/2014

Event Type  Injury  

Event Description

Initially, it was reported that the generator was loose in the pocket and is moving around.It was reported that the patient was able to reposition it when she moves her arm.X-rays were performed and sent to manufacturer for review; however, were inconclusive in confirming that the generator has migrated as there was no prior image for comparison.It was later reported that the patient was scheduled for surgery to revise the generator.Clinic notes dated (b)(6) 2014 note that the patient was seen for pre-operative visit prior to generator revision.It was noted that the patient continues to have episodes where the generator migrates upward when the patient raises her arms above he head.No known surgical intervention has been performed to date.

Event Description

Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014 to reposition her generator.

• 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: 4118837
• MDR Text Key: 4941130
• Report Number: 1644487-2014-02473
• 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
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Model Number: 105
• Device Lot Number: 3882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR