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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Pneumonia (2011)

Event Date 05/28/2015

Event Type  Death  

Event Description

It was reported that this patient died of pneumonia on (b)(6) 2015.The product was buried with the patient and is not available for return.The relationship of the death and vns is unknown.Attempts for further information were unsuccessful to date.

Manufacturer Narrative

Initial report incorrectly stated that the relationship of the death and vns was unknown.

Event Description

Based on the age of the patient and the fact that aspiration pneumonia was not reported as the cause of death, there is no indication that the death was related to 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: 5111157
• MDR Text Key: 27049319
• Report Number: 1644487-2015-05912
• 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,user f
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/09/2015

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: 08/31/2013
• Device Model Number: 102
• Device Lot Number: 201866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2011
• 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 Outcome(s): Death
• Patient Age: 94 YR