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); Post Operative Wound Infection (2446); No Information (3190)

Event Date 12/08/2020

Event Type  Injury  

Event Description

It was reported the patient was scheduled for wound revision surgery.The cause for the surgery was not reported.Device history record was reviewed for both the generator and lead.Both devices were sterilized prior to distribution, and no unresolved nonconformances were identified prior to distribution.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

Per the physician, the patient was experiencing wound deheisence.It was noted that while removing the patient's shirt, a band-aid was inadvertently peeled off over the incision/skin glue.It was noted the patient had ripped his wound dressing the second day after the surgery.The band-aids were used to cover the incision to prevent the patient from touching the incision.The physician noted that wound picking and suboptimal wound care with band-aids may have led to the premature removal of the skin glue resulting in wound deheisence.The area of wound dehiscence (-1cm) was carefully inspected and visible subcutaneous stitches were noted, but no visibly exposed hardware.The electrode could be palpated under this location.To improve healing of the site and minimize risks of infection, the decision was made to reposition the electrode and revise the wound without underlying hardware.No additional relevant information has been received to date.

Manufacturer Narrative

H3.Device evaluated by mfr?, code 81, device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

Patient had a generator explant.Leads were left implanted.It was stated the wound exploration surgery was due to infection.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.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: 11091586
• MDR Text Key: 224246007
• Report Number: 1644487-2020-01747
• 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,Followup
• Report Date: 06/07/2021

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: 07/29/2022
• Device Model Number: 1000
• Device Lot Number: 205390
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 12/28/2020; 05/13/2021
• Supplement Dates FDA Received: 01/22/2021; 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR