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

Model Number 105

Device Problem Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 04/28/2014

Event Type  Injury  

Event Description

It was reported that during the patient's initial implant surgery on (b)(6) 2014, there were difficulties identifying the nerve due to a structure with a similar appearance.Therefore, following placement of the electrodes on the structure believed to be the vagus nerve, the patient¿s generator was programmed on (output current - 2ma) in an attempt to induce bradycardia and therefore identify if the electrodes were indeed on the vagus nerve.Bradycardia was observed as intended and resolved without intervention.Therefore, it was concluded that the electrodes were properly placed.The generator was inadvertently not programmed off after the tests were completed due to communication difficulties with the programming system.As a result, the patient experienced painful stimulation, neck muscle spasms, and severe coughing until the surgeon programmed the patient's generator off and administered morphine the following day.

• Brand Name: PULSE GEN MODEL 105
• 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: 3825172
• MDR Text Key: 4503284
• Report Number: 1644487-2014-01138
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2015
• Device Model Number: 105
• Device Lot Number: 3840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2014
• 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: 29 YR