MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problem Fracture (1260)

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

Event Date 01/20/2017

Event Type  malfunction  

Event Description

High impedance of 9000 ohms was observed for patient's device.Patient underwent lead revision surgery as a result.The explanted lead has not been received to date.

Event Description

The suspect lead was received.Analysis is underway but has not been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

A portion of the lead assembly was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis the connector pin quadfilar coil appeared to be broken approximately 185 mm and 192 mm from the end of the connector boot.Scanning electron microscopy was performed on the connector pin quadfilar coil break and the area was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, fine pitting on one of the broken coil strands and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on two of the broken coil strands.Scanning electron microscopy was performed on the connector pin quadfilar coil break and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type.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 openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.Based on the findings in the lab, there is evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the stated high impedance.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.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: LEAD MODEL 304
• 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: 6330832
• MDR Text Key: 67438657
• Report Number: 1644487-2017-03207
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2012
• Device Model Number: 304-20
• Device Lot Number: 201079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2009
• 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: 13 YR