MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/29/2021

Event Type  Injury  

Event Description

The surgeon reported that during initial implant, the patient experienced a bleed that he attributed to the tunneler being too thick and not sharp enough, which he says makes the tunneler difficult to control and take too much force.Although product labeling instructs that the tunneler be used from the neck incision to the generator incision, the surgeon used the tunneler from chest to neck incision.The bleed occurred in the neck pocket in a superficial vein.The doctor applied pressure to the bleed and tied it off with 2-0 silk.The patient was tilted so the bleed site was above the feet to confirm that no further bleeding occurred.No transfusion was required.The manufacturer's device history records of the tunneler and lead were reviewed.The tunneler and the lead passed final qualifications prior to release for distribution.No further relevant information has been received to date.

Manufacturer Narrative

B5.Describe event or problem, corrected data: the following information was inadvertently omitted from the initial mdr "the operative notes indicated that the procedure had no complications and that the blood loss was minimal." f10, adverse event codes, corrected data: code f11 was inadvertently omitted from the initial mdr.

Event Description

The operative notes indicated that the procedure had no complications and that the blood loss was minimal.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 12348857
• MDR Text Key: 267493007
• Report Number: 1644487-2021-01172
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: 09/14/2021

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: Health Professional
• Device Model Number: 304-20
• Device Lot Number: 205534
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR