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

Model Number 102

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Fatigue (1849); Headache (1880); No Code Available (3191)

Event Date 12/01/2014

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that the patient is looking to explant the vns device.The patient states that she needs the device removed because for the last several years she has complained of fatigue, diarrhea, decreased libido, headaches, blood pressure fluctuations and slurred speech.Follow-up with the physician showed that these issues are thought to be related to vns therapy, resulting in vagus nerve dysfunction.

Event Description

Additional information was received that the patient¿s device was off and needs a brain mri.The patient then called and reported that the device has been off since 2008.No additional 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 4634916
• MDR Text Key: 21852624
• Report Number: 1644487-2015-04237
• 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: Health Professional,company representative,hea
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/10/2007
• Device Model Number: 102
• Device Lot Number: 014818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2006
• 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): Required Intervention
• Patient Age: 45 YR