MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Fracture (1260); Material Twisted/Bent (2981)

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

Event Date 05/10/2022

Event Type  malfunction  

Event Description

It was reported that patient was seen with high impedance and low output current not being delivered.No known relevant surgical intervention has occurred to date.No additional or relevant information has been received to date.

Event Description

It was reported that the patient underwent a full revision.The explant reason was noted to be "dislocation related to twisting compulsion".It is unknown if any lead damage had occurred in tandem with the lead becoming un-inserted.No additional or relevant information has been received to date.

Event Description

It was reported that incomplete pin insertion was noted to not be an issue despite previous reports.The lead was noted to be twisted/damaged in one are on the inferior distal edge noted to be due to patient manipulation.No other relevant information has been received to date.

Event Description

It was reported that the generator and lead are unavailable for return.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 14592540
• MDR Text Key: 293492854
• Report Number: 1644487-2022-00646
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/25/2012
• Device Model Number: 302-20
• Device Lot Number: 2296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 06/24/2022; 07/25/2022; 08/26/2022
• Supplement Dates FDA Received: 07/19/2022; 08/17/2022; 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2009
• 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: 29 YR
• Patient Sex: Female