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

Model Number 304-20

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2018

Event Type  malfunction  

Event Description

Initial report was that a patient was referred for generator replacement due to desire for latest model.Further information was received on the day of replacement that high impedance was observed on the lead during the surgery.The lead appeared to be sutured down resulting in lead damage and the lead was reported to be opened when the surgeon was assessing the lead in surgery.During the surgeon's assessment of the lead, the lead ripped.Further information was received that a stitch had been used by the previous surgeon to secure the lead to tissue and that the lead was either pierced with a needle or that the stitch wore through the lead overtime resulting in the damage.It is stated that the lead's insulating coating cracked significantly resulting in the high impedance.The surgeon proceeded with lead replacement.The lead was returned and is pending product analysis completion.No other relevant information has been received to date.

Event Description

Lead product analysis was performed.Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Setscrew marks were seen on the marked connector pin providing evidence that proper contact between the setscrew and the marked connector pin existed at least once.Other than typical wear and explant related observations (and the prior noted anomalies), no anomalies were identified in the returned lead portions.Generator analysis was completed.The product analysis lab confirmed that the generator was at normal ifi-no condition.High impedance was not observed on the generator.There were no performance of any other type of adverse events found with the pulse generator.The generator worksheet was received and there were no issues observed.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8128889
• MDR Text Key: 129219432
• Report Number: 1644487-2018-02179
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/13/2016
• Device Model Number: 304-20
• Device Lot Number: 3287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2012
• 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: 48 YR