MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Pain (1994); Paralysis (1997); Neck Pain (2433); No Information (3190); No Code Available (3191)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the sales representative that the patient went to the er.It was noted that the patient was experiencing painful stimulation and their device was programmed off.It was noted that the patient had not been interrogated in a year.The patient was seen and attempted to have their device programmed on.The patient had a coughing fit, voice alteration and painful stimulation.The patient pain was reported to start at the neck and goes up to the ear.It was noted by the patient that the emergency room physician said that the patient may have vcp.No known surgery has occurred to date.No additional relevant information has been received to date.

Manufacturer Narrative

F10.Event problem codes - patient code - correction - code 3190 was inadvertently reported in the initial mdr, however the event of coughing and voice alteration should have been captured with the code of 3191 - no code available.F10.Event problem codes - patient code - correction - code 1994 should have been reported in the initial mdr for the event of ear pain.H6.Evaluation codes - conclusions - correction - code 22 should have been included in the initial mdr.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10536306
• MDR Text Key: 207026165
• Report Number: 1644487-2020-01213
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

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: 08/31/2018
• Device Model Number: 106
• Device Lot Number: 203931
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 58 YR