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

Model Number 105

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

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Weight Changes (2607)

Event Date 05/05/2014

Event Type  Injury  

Event Description

It was reported that the patient was having muscle spasms and that her generator will be revised because it is at a different angle.It was reported that it is believed that the angle the generator is at is causing pain.The device was disabled on (b)(6) 2014 and the patient was referred for surgery for patient comfort; however, it was also a precaution to make sure the generator isn't "misfiring" and cause a serious injury.On (b)(6), the patient came back in and the device was deactivated.The patient was referred for surgery and it was for patient comfort however it was also as a precaution to make sure that the generator isn't "misfiring" and could cause a serious injury.(b)(4) provided the system diagnostic results as ok impedance 3620 ohms and ifi - no.The patient underwent generator revision on (b)(6) 2014 due to a 90 pound weight loss.The surgeon reportedly did not identify any problems with the lead when the generator was revised.There was no history of trauma to the area or falls.X-rays were taken and sent to manufacturer for review.Based on the x-rays received, the report of device migration and discomfort cannot be analyzed.There was nothing seen that would indicate there was any damage to the generator or lead; however, the presence of a micro-fracture in the lead cannot be ruled out.As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed.It was reported that the patient would be seen to have the device programmed back on.No additional relevant information has been received to date.

Event Description

Additional information was received stating that the vns patient was experiencing muscle spasms in her neck.The patient underwent surgery on (b)(6) 2014 to explant her generator.The explanted generator has not been returned to date.

Event Description

The explanting facility discarded the explanted device; therefore, no analysis can be performed.Additional information was received stating that the vns patient responded well to vns therapy.

Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device.X-rays reviewed by the manufacturer did not identify any discontinuities with the vns system.

• 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: 3909389
• MDR Text Key: 4588041
• Report Number: 1644487-2014-01663
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: 105
• Device Lot Number: 3581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 07/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/08/2014; 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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: 28 YR