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 Paralysis (1997); Pneumonia (2011); Vomiting (2144); Convulsion, Clonic (2222); Discharge (2225)

Event Date 09/03/2020

Event Type  Injury  

Event Description

It was reported that soon after the vns was turned on, the patient had been vomiting and had a fever.The patient was admitted to the hospital due to retching and gagging.It was noted that the patient suffers from overproduction of saliva and the device had been activated to settings that were too high.The physician believed this to be the cause of the issues and disabled the device.The patient's mother noted that the patient's secretions were so bad after the device was turned on that it caused him to aspirate and have pneumonia.The patient was given antibiotics.No issues were noted with device diagnostics.No other relevant information has been received to date.

Event Description

Information was received that system diagnostics were performed when the events were first reported and all were normal, and the device was rechecked again when the patient was admitted to the hospital.It was noted that the patient's mother mentioned wanting the device to be removed.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was reported that the patient has been experiencing foot drop since vns surgery.It was noted the patient also has history of cerebral palsy and osteopenia.Information was received that the nurse practitioner does not really think the foot drop was related to vns, but the patient's physical therapist assessed that it may have been due to all of the seizures the patient was having post-implant.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

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 white 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." this information was originally reported in mfr.Report # 1644487-2021-00319 as this related report was not originally found.Information was received from the physician he did not confidently associate vns with any respiratory or upper airway problems in a causal mechanism.No other relevant information has been received to date.

Manufacturer Narrative

B5: corrected information, initial report: inadvertently did not include the summary of events which was previously reported in mfr.Report #1644487-2021-00319.

• 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: 10634976
• MDR Text Key: 209987350
• Report Number: 1644487-2020-01332
• 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,consum
• Type of Report: Initial,Followup,Followup,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: 09/11/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/06/2020; 02/03/2021; 03/11/2021
• Supplement Dates FDA Received: 10/29/2020; 02/26/2021; 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23 YR