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

Model Number 102

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

Patient Problems Death (1802); Coma (2417); No Code Available (3191)

Event Date 09/02/2018

Event Type  Death  

Event Description

It was reported that the patient was hospitalized after being found in a coma.In the hospital it was reported that he was in a bad state and had thrombocytopenia.The patient had reported the day prior to hospitalization that he felt stimulation in his left neck when bending down.The physician in charge of the patient at the hospital was not sure whether the symptoms and current state of the patient could be related to vns.The manufacturer's device history records of the patient's generator was reviewed.The generator passed final quality and functional specifications prior to release.No further relevant information has been received to date.

Event Description

It was reported that the patient passed away approximately two months after the onset of the coma.The attending doctor believed that the death was likely caused by cerebral ischemia with anoxia.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, 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: 7923538
• MDR Text Key: 122222445
• Report Number: 1644487-2018-01736
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/11/2019
• Device Model Number: 102
• Device Lot Number: 5269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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; Hospitalization
• Patient Age: 18 YR