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

Model Number 102

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); High impedance (1291)

Patient Problems Fall (1848); Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2016

Event Type  malfunction  

Event Description

It was reported by a company representative that a patient¿s vns device had high impedance and was referred for revision surgery.Revision surgery occurred (b)(6) 2016.Follow-up from the company representative who attended the case provided that the patient had high impedance after he had a fall during a seizure.Prior to surgery diagnostics were performed and showed high impedance, and a second set of diagnostics which also showed high impedance.In surgery, the chest pocket was opened and it was discovered that the old generator was implanted under the muscle.When the surgeon was taking the generator out, he said the header was broken and the filter feed-thru wires were already pulled out.After he took the generator out, the header fell completely off.Since the generator was under the muscle, the surgeon thinks the fall may have caused the generator to be pushed up against the bone and broke the header.The new generator was put on the old leads, above the muscle and the diagnostics were within normal limits.The lead was not revised.The explanted device has not been received by the manufacturer to-date.Additional relevant information has not been received to-date.

Event Description

The explanted devices were received by the manufacturer.Analysis is underway, but has not been completed to-date.

Event Description

Analysis was completed for the returned generator.The reported detachment of header was confirmed.The reported high impedance was confirmed as well, as the output wires from the header were completely broken.After test wires were connected to the device¿s output, the device met functional specifications.With the exception of the header detachment, analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.

• Brand Name: PULSE GEN MODEL 102
• 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: 6105078
• MDR Text Key: 60448036
• Report Number: 1644487-2016-02647
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2013
• Device Model Number: 102
• Device Lot Number: 2934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2011
• 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 Age: 47 YR