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

Model Number 103

Event Date 08/28/2013

Event Type  Injury  

Event Description

Additional information was received from the neurologist stating that following replacement surgery, the vns patient had severe difficulty swallowing, nerve damage, laryngeal issues, and aspiration. The patient¿s symptoms were reported to be somewhat better.

Manufacturer Narrative

Describe event or problem, corrected data: supplemental manufacturer report #01 inadvertently did not include the additional information received from the neurologist.

Event Description

On (b)(6), 2013, the patient's father reported that the patient has been experiencing several adverse events after having his most recent vns replacement on (b)(6), 2013. The adverse events included losing his voice, coughing and choking while he eats, aspiration pneumonia, and a hole in an unspecified location. Attempts for additional information have been made; however, they were unsuccessful. No additional information has been provided.

Manufacturer Narrative

Event Description

The patient was seen for follow-up with the surgeon. The device interrogation was within normal limits. The surgeon indicated that he initially thought the patient's issues were due to the patient being intubated for implant surgery. The surgeon indicated that the patient likely has recurrent left laryngeal polyps which he feels will continue to heal over the next six months. The surgeon offered the patient a follow-up appointment in three months. The surgeon reported that it is reasonable that scar tissue could have been dissected and such outcomes would be reasonable to occur.

• Brand Name: PULSE GEN MODEL 103
• 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: 3528864
• Report Number: 1644487-2013-03855
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2013

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/19/2013
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 05/31/2015
• Device MODEL Number: 103
• Device LOT Number: 202553
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/21/2014
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 06/25/2013
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 12/19/2013 Patient Sequence Number: 1