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

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 02/25/2014

Event Type  Injury  

Event Description

It was reported that the vns patient fell off a horse on (b)(6) 2014.During an office visit the following day, the patient reported pain occurring with stimulation.The device was subsequently programmed off but the pain persisted.Diagnostic results revealed normal device function at the time.The patient underwent generator and lead replacement surgery due to pain on (b)(6) 2014.The patient's pain had resolved since the replacement surgery, which was performed as a precaution and for patient comfort.The neurologist also noted that the patient¿s fall may have ¿dislodged¿ the device.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Event Description

The neurologist also noted that the patient¿s fall may have ¿dislodged¿ the device again.It is unclear when the previous occurrence was as a previous report of painful stimulation subsided with device disablement.Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.Review of the decoder data did not reveal any anomalies.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.Abrasions were observed in various locations, possibly caused by wear.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints.Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.

Event Description

The patient's mother reported that the patient was involved in a motor vehicle accident in (b)(6) 2013 where the car went off of the road and over a six foot culvert.The vehicle landed on the passenger side and caused the patient to dangle from the seat belt.The mother noted that the painful stimulation did not occur until (b)(6) 2014 and the patient was instructed to tape the magnet over the generator to disable the device.The following day, the patient was seen by the physician.The physician removed the magnet and the patient again experienced painful device stimulation.The device was programmed off for three days and when programmed back to on, the patient again experienced painful stimulation.

Manufacturer Narrative

Describe event or problem, corrected data: the initial manufacturer report inadvertently did not specify that the patient¿s fall may have ¿dislodged¿ the device again.

Event Description

Operative notes from the surgeon reported that because of intermittent painful stimulation, there was concern of a microfracture of the lead or a generator issue.The patient also believed something was wrong with the device.No further relevant information has been received to date.

Manufacturer Narrative

The initial portion of the event description in supplemental mdr 2 was corrected as supplemental mdr 2 inadvertently implied that it was alleged that the motor vehicle accident had caused the painful stimulation in (b)(6) 2014 for which intervention had occurred.

Event Description

The patient's mother reported that the patient first time the patient had experienced painful stimulation was involved in a motor vehicle accident in (b)(6) 2013 where the car went off of the road and over a six foot culvert.The vehicle landed on the passenger side and caused the patient to dangle from the seat belt.The mother noted that the painful didn't have painful stimulation again until (b)(6) 2014, which was already reported as when the patient fell off her horse, and the patient was instructed to tape the magnet over the generator to disable the device.

• 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: 3735544
• MDR Text Key: 4224139
• Report Number: 1644487-2014-00873
• 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: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2013
• Device Model Number: 103
• Device Lot Number: 201854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2011
• 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: 17 YR