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

Model Number 300-20

Device Problem Fracture (1260)

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

Event Date 04/12/2018

Event Type  malfunction  

Event Description

The neurologist had noted high impedance for patient's device.Patient underwent generator and lead revision due to high impedance.The explanted lead has not been received to date.

Event Description

The explanted lead and generator were received.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were performance or any other type of adverse conditions found with the pulse generator.During the visual analysis of the lead, electrode quadfilar coil appeared to be broken.Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, no pitting and residual material on two of the broken coil strands.Residual material was observed on the coil surface.Scanning electron microscopy was performed on the other end and identified the area as being mechanically damaged which prevented identification of the coil fracture type, fine pitting and residual material on three of the broken coil strands.Pitting and residual material was observed on the coil surface.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution.With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 7574371
• MDR Text Key: 110356733
• Report Number: 1644487-2018-00969
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2001
• Device Model Number: 300-20
• Device Lot Number: 19323C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/1999
• 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: 40 YR