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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2006

Event Type  malfunction  

Event Description

It was reported by the patient that his vns had been "non-functional" for a few years and was no longer working.A battery life calculation was performed, which did not support battery depletion as a cause of the device being "non-functional." the patient requested to have his device explanted.Programming history showed that diagnostics were within normal limits throughout the available history.The patient's device was programmed to relatively low settings.Attempts for further information were unsuccessful to date.No surgical intervention has occurred to date.

Manufacturer Narrative

Device available for evaluation, corrected data: the initial report inadvertently did not report that the devices were received.(b)(4).

Event Description

Clarification was received that the device being "non-functional" was actually lack of efficacy.The patient had explant surgery because she needed to have an mri performed, and the generator and lead were received for analysis.Analysis on the generator was approved.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 device performed according to functional specifications.Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.Analysis on the lead has not been approved to date.

Event Description

Analysis on the lead was approved.Note that a portion of the lead assembly (body) including the electrodes was not available for analysis, and therefore a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The set screw marks found on the lead connector pin provided evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed with no discontinuities identified.There was no evidence to suggest an anomaly with the returned portions of the device.

• 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: 6610142
• MDR Text Key: 76599982
• Report Number: 1644487-2017-03911
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/11/2007
• Device Model Number: 102
• Device Lot Number: 013894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2005
• 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: 42 YR