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 Wound Dehiscence (1154); Edema (1820); Unspecified Infection (1930); No Code Available (3191)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary as the edema and wound dehiscence are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient is experiencing redness and swelling at their lead site and redness, swelling and partial separation at the chest pocket wound site where the recent m1000 replacement and repositioning of the pin was done.It was clarified that this reported swelling is different than the swelling occurring prior to the surgery.The surgery was not done around the lead area.Information was received that the patient is still in the hospital on iv antibiotics and will be for two months.The patient was taken to the or again for a flush out of the generator pocket and antibiotic pellets inserted into the generator pocket.Device history records were reviewed for the generator and the device passed all functional specifications and quality tests and were sterilized prior to distribution.No additional relevant information has been received to date.

Event Description

It was reported that the patient is still in the hospital had a washout and antibiotic pellets every two weeks and iv antibiotics.The patient's mother stated the last two cultures taken were "clean".Further information was received that the patient had their 4th surgical washout.No additional relevant information has been received to date.

Event Description

Information was received that the patient underwent full vns explant due to infection and the patient's wound culture was positive for pseudomonas.It was also noted that patient may have staph infection now.No additional relevant information has been received to date.

Manufacturer Narrative

Section f10.Patient code - corrected data: code 1930 and 3191 inadvertently not coded on supplemental #2 mdr.Section h6.Evaluation codes - conclusions, corrected data: code 4311 and 22 inadvertently not coded on supplemental #2 mdr.

Event Description

Information was received that the believed cause of the redness and swelling at the lead site and chest pocket is related to the recent vns surgery.It was also stated the cause of the wound separation is due to the recent vns surgery.Intervention was taken for the redness and swelling, "site washed out multiple times' and the intervention was to preclude a serious injury.No additional relevant information has been received to date.

• 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: 9782193
• MDR Text Key: 182370460
• Report Number: 1644487-2020-00379
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 01054250257504051
• 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,Followup,Followup,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2021
• Device Model Number: 1000
• Device Lot Number: 205121
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 14 YR