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

Model Number 102

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problems Arrhythmia (1721); Death (1802); Myocardial Infarction (1969)

Event Date 03/05/2014

Event Type  Death  

Event Description

It was reported that the patient passed away from an unknown reason.It was reported that the device was explanted and would be sent to manufacturer for analysis.The medical examiner indicated that the patient's vagus nerve was explanted with the lead attached to avoid damaging the lead electrodes.The relationship between vns and the death is known.The generator and lead were returned for analysis.The reason for explant was reported as sudden unexpected death with recent history of myocardial infarct (non-ischemic) and possible arrhythmia.The generator analysis was completed on (b)(6) 2014.The device performed according to functional specifications.Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.The lead analysis was completed on (b)(6) 2014.The slice marks found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes.The marks appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed.During the visual analysis the (+) white and (-) green electrodes appeared to be embedded in what appeared to be remnants of dried body tissue.This condition may have prevented the (+) white and (-) green electrode ribbons from coming in contact with the vagus nerve.With the exception of the observed tissue-covered (+) white and (-) green electrodes the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion 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: 3738321
• MDR Text Key: 19765950
• Report Number: 1644487-2014-00954
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2014

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: 01/31/2008
• Device Model Number: 102
• Device Lot Number: 015168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/12/2014
• Initial Date FDA Received: 04/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2006
• 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): Death; Other
• Patient Age: 69 YR