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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Device Contamination with Body Fluid (2317)

Patient Problem Depression (2361)

Event Date 10/20/2020

Event Type  malfunction  

Event Description

It was reported there was a lead fracture and patient could no longer perceive stimulation.X-rays were performed and patient was referred to surgeon.No known surgery has occurred to date.No additional information has been received to date.

Event Description

Additional information was received by the surgeon that the patient was taken to surgery to replace vns due to a malfunction.The patient with depression reported worsening symptoms over the last year.During the or, it was noted after dissection of tissue in the generator pocket that the lead was twisted up and fractured 2 cm behind the generator therefore the pin was no longer connect to the generator.Full revision was performed, and patient recovered well after surgery.The suspect explanted product has not been received to date.

Event Description

The explanted product were returned for analysis and is currently ongoing.

Event Description

Product analysis for the generator was completed.The pulse generator was explanted/returned due to ¿prophylactic replacement¿.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from the generator), demonstrate the appropriate magnet current for the programmed settings.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the device performed according to functional specifications.The battery, 2.902 volts as measured during completion of the final electrical test, shows an ifi=no condition.There were no performance, or any other type of adverse conditions found with the pulse generator.Pa worksheet was reviewed and no anomalies were found.The datadump was reviewed and the >25% change took place on 10/20/20.The prechange was 2059 ohms and the postchange was 14607 ohms.This shows high impedance occurred prior to the date that it was found.No additional relevant information has been received to date.

Event Description

Product analysis (pa) for the lead was completed.The reported fracture of lead was verified.The outer silicone tubing is abraded open.The lead assembly is torn at approximately 0.1cm from the end of the connector boot suggesting lead manipulation by the patient (twiddler)¿.Scanning electron microscopy (sem) image of the coil broken ends show that pitting or electro-etching condition have occurred at the end of the positive coil.Sem also shows the positive and the negative lead coils break mate ends show that a stress induced fracture (due to rotational forces) has occurred in the lead coils.Secondary stress-fissures were note in the vicinity of the coil broken ends.There were no other anomalies noted besides those mentioned.Pa worksheet was reviewed and noted fluid was found inside the inner and outer abraded openings.Figure and visual sheets were reviewed, and no other anomalies noted other than those already mentioned.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11784383
• MDR Text Key: 249523528
• Report Number: 1644487-2021-00610
• Device Sequence Number: 1
• Product Code: MUZ
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/07/2016
• Device Model Number: 304-20
• Device Lot Number: 202208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Event Location: Other
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR