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

Model Number 102

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

Patient Problems Debris, Bone Shedding (1803); Liver Damage/Dysfunction (1954); Renal Failure (2041); Respiratory Distress (2045)

Event Date 06/14/2013

Event Type  Death  

Event Description

It was reported that the vns study patient passed away on (b)(6) 2013.The national death index from the cdc website listed the patient's cause of death as unspecified cirrhosis of liver, pneumonia, acute respiratory failure, and chronic kidney disease (stage 5).The relationship of the death to vns is unknown.No further information relevant to the patient's death has been received to date.Based on the available information about the patient¿s death, an internal classification has determined that the death was unlikely sudep.

Manufacturer Narrative

The initial report inadvertently reported the death when there was no believed relationship to vns.This event should not have been reported.Evaluation codes, corrected data: the initial report inadvertently reported the death when there was no believed relationship to vns.No device failure is suspected.This event should not have been reported.

Event Description

Based on the causes of death, there is no suspected relationship between the death and vns.

• 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: 4925881
• MDR Text Key: 6429607
• Report Number: 1644487-2015-05263
• 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: Other,Study,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2015

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: 06/30/2008
• Device Model Number: 102
• Device Lot Number: 015709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2006
• 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
• Patient Age: 65 YR