MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Pain (1994); No Code Available (3191)

Event Date 11/01/2019

Event Type  Injury  

Event Description

Patient noted that they would like their device removed as it bother them at night when they sleep and that it moves around a little bit.Patients device was noted to have been programmed off since 2017.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Information was received from the physicians office noting that the patient had discomfort in their neck, which has resolved after programming the patients device off.The physician noted that the discomfort is due to the presence of the vns device and that they believe the patient was over stimulated after the patients revision.The migration was noted to have occurred at the generator site; however, the physician does not know the cause of the migration or if non-absorbable sutures implanted.The revision/explant surgery was noted to be for patient comfort.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 9438826
• MDR Text Key: 169892300
• Report Number: 1644487-2019-02373
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

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: 05/28/2016
• Device Model Number: 105
• Device Lot Number: 203008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 64 YR