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

Model Number 102R

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 12/03/2008

Event Type  Death  

Event Description

It was reported that the patient passed away on (b)(6) 2008 but the cause of death is unknown.The death certificate was unable to be obtained.An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.Attempts were made for additional relevant information but it has not been received to date.

Manufacturer Narrative

Brand name, corrected data: pulse gen model 102r.Model #, corrected data: 102r.Serial #, corrected data: (b)(4).Lot #, corrected data: 015484.Expiration date (ma/day/yr) corrected data: 03/31/2008.If implanted, give date (mo/day/yr), corrected data: (b)(6) 2006.Device manufacture date (mo/day/yr),corrected data: 05/23/2006.Initial mdr inadvertently listed the wrong product information.

• Brand Name: PULSE GEN MODEL 102R
• 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: 5518747
• MDR Text Key: 40923312
• Report Number: 1644487-2016-00623
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

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: 03/31/2008
• Device Model Number: 102R
• Device Lot Number: 015484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2006
• 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: 36 YR