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

Model Number 102R

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

Patient Problem Tissue Breakdown (2681)

Event Date 01/24/2017

Event Type  Injury  

Event Description

A call was received from the hospital requesting a product return number as the patient had undergone vns generator and lead explant due to wound dehiscence.The patient had been admitted to the er a few days prior to the explant surgery due to an unrelated issue, and the physician reported to the surgeon that he was able to see the generator through the patient's incision.It was confirmed there was no sign or suspicion of infection.Review of the dhr for the generator confirmed sterilization prior to distribution.

Event Description

Product analysis (pa) for the returned generator was completed.The reported ¿extrusion/generator¿ allegation is beyond the scope of the activities performed in the pa laboratory.During analysis, it was found that the device performed according to functional specifications and concluded that no abnormal performance, or any other types of adverse conditions, was found.It was later reported by the physician's office that they believe the patient had picked at the incision, which caused the extrusion.Pa for the returned lead was completed.The allegation of extrusion is not an actionable issue which will result in confirmation of an event and identification of a casual factor in the pa laboratory environment.Note that the lead assembly, including the electrode section, was not returned for analysis and thus a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device.

• Brand Name: PULSE GEN MODEL 102R
• 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: 6341897
• MDR Text Key: 67800345
• Report Number: 1644487-2017-03226
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/26/2017
• Device Model Number: 102R
• Device Lot Number: 203672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2016
• 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: 67 YR