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

Model Number 304-30

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that during the patient's initial implant, the surgeon was unable to insert the lead pin into the generator despite multiple troubleshooting attempts.As the generator was the suspected issue, a new one was used and attempted however before insertion occurred, the surgeon noted that the leads had sustained damage from the manipulation.No details on what damage was seen.A second set of leads was used with the backup generator and implanted successfully.Post op diagnostics were noted to be ok.It is unknown what caused the initial insertion difficulties.Further information was received from (b)(6) indicating that the initial implant difficulties were due to the pin did not fit adequately in to generator according to the surgeon.In regards to the leads looking "off" the surgeon believed that pin was damaged (and requested new leads) when she attempted to force the pin into the generator with clamps.Device history records were reviewed.The device passed all functional and quality testing prior to distribution.The device has been received into product analysis which is underway but not yet completed.No other relevant information has been received to date.

Event Description

Product analysis was completed and approved.A bench in-line lead fully inserted into the pulse generator header, past the negative connector block.The returned lead connector was also inserted completely in the header of a representative pulse generator header and it was also inserted completely in the header of pulse generator m1000 sn: (b)(6).No anomalies preventing the connector pin from being fully inserted into the generators were noted.In addition, the four sets of set screw marks on pin indicate the lead was inserted into a generator header at one point in time.Continuity checks of the returned lead portion was performed during the functional analysis, and no discontinuities were identified.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16357015
• MDR Text Key: 309378612
• Report Number: 1644487-2023-00171
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750153
• UDI-Public: 05425025750153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 304-30
• Device Lot Number: 205926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Female