MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Seizures (2063)

Event Date 10/01/2016

Event Type  Injury  

Event Description

A patient was seen in the hospital due to a seizure and during the visit she noted that the generator had moved around and she wanted it repositioned.The system diagnostic test performed when the event was reported showed that the device was performing as intended.The patient was referred for a battery adjustment due to the migration.No further clarifying information was provided on whether or not the surgery referral was to prevent permanent impairment or if it was for comfort purposes.The patient did not report experiencing any trauma.The generator was verified to pass all quality inspections prior to release for distribution.No further relevant information has been received to date.

Event Description

A fax was received from the patient's neurologist who referred her to the surgeon and he stated that the patient was referred for surgery due to both comfort purposes and to preclude a serious injury.No known surgical intervention has occurred to date.

Event Description

It was reported that the patient's device had been repositioned.It was reported that after the surgery, interrogation of the device showed that the battery was at eos pulse-disabled which is reported in mfg report #: 1644487-2017-03015.No additional relevant information has been received to date.

Manufacturer Narrative

Device evaluation is not necessary with regards to the event of migration reported in this report because the migration was determined to not be due to expected device function and was due to the surgeon failing to follow labeling instructions.

Event Description

The surgeon that implanted the patient's generator reported that he had not used a suture to secure the generator during the implant surgery.No additional relevant information has been received to date.

Event Description

It was determined that the generator voltage dropped suddenly on the date of the repositioning surgery, where pulse-disabled status was triggered.This indicates that the generator was likely exposed to electrostatic discharge during the repositioning surgery.This event is captured in mfr.Report # 1644487-2017-03015.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• 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: 6142236
• MDR Text Key: 61347139
• Report Number: 1644487-2016-02776
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/18/2015
• Device Model Number: 103
• Device Lot Number: 202502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention
• Patient Age: 29 YR