MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Ambulation Difficulties (2544); Aspiration Pneumonitis (4455); Cough (4457)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A series of events was reported by the patient's mother regarding issues the patient has had with their vns.The patient's mother did not notice any vns side effects for the remainder of the day after activation.The day after, on (b)(6) 2020, the mother noticed "coughing and a lot of mucous, but did not think much of it due to history of allergies, frequent sinus infections, or maybe just viral." on (b)(6) 2020, the patient was seen in ed for fever and increase in secretions.He was given fluids and his fever improved, so he was discharged home.Mother asked "dr (b)(6) in ed, if his body could be rejecting vns and she agreed it could be a possibility." the patient returned to the ed on (b)(6) 2020 after he "went downhill aggressively." the tc noted that "saturations" did not come up between his seizures.He was diagnosed with "aspiration pneumonia." the next day,(b)(6) 2020, the physician deactivated vns while in the icu.Per his mother "after they deactivated it, the patient improved." the patient was then discharged on (b)(6).After being discharged from icu, "it took a long time to gain his strength".It was stated that once the patient could walk again, his foot was just hanging and the physical therapist said his foot drop could be related to status." per the mother, "he is back to his normal baseline." information was received that per the physician, diagnostics were within normal limits.No additional relevant information has been received to date.

Manufacturer Narrative

Identical report captured in manufacturing report#: 1644487-2020-01332.

Event Description

Information was received that the physician stated in reviewing this case, the physician did not confidently associate vns with an respiratory or upper airway problems in a causal mechanism.An identical report was found to house the report of secretion, vomiting, pneumonia, increase in seizures, and paralysis for the same patient and thus all further information received for this patient and report will be contained and reported in manufacturing report#: 1644487-2020-01332.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11425523
• MDR Text Key: 238328234
• Report Number: 1644487-2021-00319
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: 04/05/2021

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: 02/17/2022
• Device Model Number: 1000
• Device Lot Number: 205213
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR