MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 09/01/2014

Event Type  Injury  

Event Description

It was reported that the patient was having painful stimulation in his throat that he believed to be due to the generator reaching end of service.The patient stated that something similar occurred when his last generator reached end of service.The patient also reported that the generator was going off more often.The physician confirmed that the generator was not at end of service but the patient was insistent to have it replaced.Surgery is likely but has not occurred to date.

Event Description

On (b)(6) 2014 it was reported that the patient underwent prophylactic generator replacement on (b)(6) 2014.The explanted generator was returned for product analysis on (b)(6) 2014.Product analysis is still underway and has not yet been completed.

Event Description

On (b)(6) 2014, product analysis was completed on the explanted generator.The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.The generator performed according to functional specifications, there were no anomalies found with the pulse generator.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 102
• 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: 4209245
• MDR Text Key: 4963849
• Report Number: 1644487-2014-02863
• 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,Followup,Followup
• Report Date: 09/30/2014

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: 02/28/2011
• Device Model Number: 102
• Device Lot Number: 2344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 10/29/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/02/2014; 01/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2009
• 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: 42 YR