MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Fracture (1260); Mechanical Problem (1384)

Patient Problem Pain (1994)

Event Date 11/12/2019

Event Type  malfunction  

Event Description

It was reported that patient was having vns revision due to lead break.High impedance was seen through diagnostics.X-rays were performed by the physician however results from x-rays are unknown.Information was later received that generator and lead were explanted.Explanted product have not been received for product analysis to date.No additional relevant information has been received to date.

Manufacturer Narrative

Event description - correction - inadvertently did not include that products were received for product analysis in the initial mdr submitted serial #, lot #, and expiration date - correction - inadvertently incorrect device information was listed in the initial mdr submitted.If implanted, give date ¿ correction ¿ inadvertently incorrect implant date was listed in the initial mdr submitted.Device available for evaluation? - correction - inadvertently did not include that products were available for product analysis in the initial mdr submitted.Device evaluated by mfr? - correction - inadvertently did not include that products were being evaluated in product analysis in the initial mdr submitted.Device manufacture date - correction - inadvertently incorrect expiration date was listing in the initial mdr submitted.

Event Description

Generator and lead were received into product analysis (pa).It was noted that patient was implanted with a different lead.Generator analysis completed and reviewed.The allegation of pain cannot be evaluated in the pa laboratory setting, proper functionality of the generator in its ability to provide appropriate programmed output currents can be verified.This was successfully verified in the pa lab.Device output signal was monitored for more than 24 hours, while the generator was placed in simulator body temperature environment.Results showed no signs of variation in the output signal and demonstrated the device provided expected level of output current for the entire monitoring period.Programmed parameters gave expected diagnostics.The generator performed according to functional specifications.The battery measure 2.814v with ifi=no and battery consumed was 65.059%.No performance or adverse conditions were found with generator.No additional relevant information has been received to date.

Event Description

Lead product analysis (pa) was completed and reviewed.Lead portions were returned due to allegation of lead fracture which was confirmed.During visual analysis of returned 165mm portion of lead the connector pin quadfilar appeared to be broken 149mm from the end of the cut connector pin connector silicone tubing.The 91 mm portion of lead with ends of quadfilar coils 1 and 2 appeared to be broken 8mm from the end of the cut/torn outer silicone tubing.Scanning electron microscopy (sem) was performed and identified the broken areas as having evidence of stress induced fracture which most likely complete the fracture and no pitting was present.Secondary break lines were observed on the coils surface.It is unknown if the break occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces.These findings are consistent with patient manipulation/ rotation of device while it was implanted.During the visual analysis of the returned 54mm portion the connector pin quadfilar coil appeared to be melted 12mm from the end of the cut connector silicone / inner silicone tubing.During the visual analysis of the returned 30mm portion the connector pin quadfilar coil appeared to be melted 16mm from the end of the cut connector silicone / inner silicone tubing.During sem, areas were identified as having the appearance of being melted, with re-solidified material as well.It is unknown exactly what caused the quadfilar coil to melt but is possible that the thermally damaged coil was exposed to a high temperature device such as a cauterizing tool during the explant of this lead.The abraded inner and outer silicone tubing seen was concluded to be related to wear.Fluid leaks were found inside the inner/outer tubing abrasion that was likely caused during the explant procedure.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pins providing evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, and no other discontinuities were identified.Note that since a portion of the unmarked connector pin quadfilar coil including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.No additional relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9835384
• MDR Text Key: 187949403
• Report Number: 1644487-2020-00429
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/03/2000
• Device Model Number: 300-20
• Device Lot Number: 1315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Event Location: Other
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR