MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Swelling (2091)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that it was known prior to implant surgery that the patient had severe cardiac issues before implant, but the patient was still implanted due to the vns benefits outweighing the risks.However, the physicians had a suspicion that the patient may have some issues after the surgery.When the case manager called the patient's girlfriend on (b)(6) 2016 to follow-up on the appointment, it was reported that the patient was still in the hospital due to clotting issues.The patient was hospitalized three days before the implant due to heparin bridging.The day after implant on (b)(6) 2016, the patient had surgery to drain the generator incision site.The neck site was also swollen and was noted that it would probably need draining also.She stated that it is not infection.It was indicated that this is not due to the vns, but because of the clotting issues that patient has due to the heparin bridging.The patient was seen on (b)(6) 2016, and the device was turned on.The patient tolerated activation well.The clotting issues had appeared to resolve, and the patient appeared to be fine.It was clarified that the fluid was in the neck, and was since absorbing after the procedure.The physician thought that the clotting was blood.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5505080
• MDR Text Key: 40534330
• Report Number: 1644487-2016-00571
• 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,consum
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2017
• Device Model Number: 106
• Device Lot Number: 4614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2015
• 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: 65 YR