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

Model Number 300-20

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Seizures, Grand-Mal (2168)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

It was reported that the patient was admitted to the hospital due to an increase in seizures.A system diagnostic test was later performed for patient and high impedance with dcdc 7 was observed.Additional information was obtained that the patient was discharged then re-admitted due to a generalized seizure.Patient was referred for replacement surgery and underwent full revision surgery on (b)(6) 2015.The explanted products are expected to be returned but have not been received to date.

Event Description

Generator and lead were returned due to lead discontinuity and were received on 11/30/2015.The generator performed according to functional specifications.During the product analysis, there were no anomalies found with the pulse generator.Analysis of the lead is underway but has not been completed.

Event Description

An analysis was performed on the returned lead portions and the reported allegations of ¿fracture of leads and high impedance¿ were confirmed.A portion of inner silicone tubing and quadfilar coil between the electrode bifurcation and anchor tether was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product.Analysis confirmed discontinuity of both positive and negative quadfilar coils in the electrode region of the returned lead portions.Scanning electron microscopy was performed on the area of the break on quadfilar coil 1; the remaining coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture.Flat spots and pitting was observed on the coil surface.Scanning electron microscopy was performed on the quadfilar coil 2 coil break area and the area was identified as having extensive pitting which prevented identification of the coil fracture type.Flat spots and pitting 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.The abraded opening found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.What appeared to be white deposits were observed in various locations.Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium.Refer to attached eds sheet for additional information.With the exception of the observed discontinuities 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): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, 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: 5246076
• MDR Text Key: 32227755
• Report Number: 1644487-2015-06548
• 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,Followup
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/17/2003
• Device Model Number: 300-20
• Device Lot Number: 2372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/22/2015; 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2001
• 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 Outcome(s): Required Intervention
• Patient Age: 18 YR