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 04/22/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, patient mentioned that she thinks the generator is drifting more laterally on her chest wall.X-rays were taken and was reported to be intact per the physician.Further attempts to learn whether non-absorbable suture was used to secure the generator in place on (b)(6) 2012 were made but were unsuccessful to date.Clinic notes were received for patient's referral for prophylactic generator replacement with the intention of addressing the generator migration at that time.Clinic notes stated that the patient's generator is dislodged from the pocket and is projecting through the skin in the armpit.The patient was referred for surgery to reseat the generator in the pocket.The device was checked and was confirmed to be working fine.The settings were increased as patient feels that she is experiencing breakthrough auras and seizures.Patient underwent prophylactic generator replacement on (b)(6) 2016.The explanted generator will not be returned to manufacturer by the hospital.Additional relevant information has not been received to date.

Event Description

Additional information was received that the patient did experience an increase in seizures and auras but its below pre-vns baseline and is not believed to be related to vns.This will not be captured/coded as a result.The physician is uncertain on the cause of device migration.

• 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: 5853731
• MDR Text Key: 51383422
• Report Number: 1644487-2016-01778
• 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
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2013
• Device Model Number: 103
• Device Lot Number: 201734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2011
• 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): Other
• Patient Age: 41 YR