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 Problem Death (1802)

Event Date 11/24/2007

Event Type  Death  

Event Description

It was found through an obituary search that the patient had passed away.A battery life calculation was reviewed and showed the device was working as intended as the dcdc value was within normal limits.No anomalies were observed.Additionally, the battery life calculation estimation showed approximately 9.4 years were remaining at the time of the patient's death; therefore, the device was likely still functioning.It was later reported by the patient's last known physician that he saw the patient the spring prior to her death.He stated he believed the death was not related to vns; however, since he did not see her at the time of her death, he could not be certain.Additionally he noted the patient also had lung issues (unrelated to vns) and rhett's syndrome.

Event Description

A death certificate was later received showing the patient died of leukopenia, anemia, and thrombocytopenia.The death was noted to be natural.

• 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: 6438083
• MDR Text Key: 70966931
• Report Number: 1644487-2017-03491
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2005
• Device Model Number: 102
• Device Lot Number: 8625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 03/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2003
• 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: 24 YR