MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problems Fracture (1260); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Seizures (2063); Shock from Patient Lead(s) (3162)

Event Date 04/01/2016

Event Type  malfunction  

Event Description

Clinic notes were received on 04/07/2016 for patient referral for surgery.The notes state that the last visit her settings were adjusted to 1.25ma/30 sec.The patient came to the office today with a one week history of feeling electrical shocks in her neck.Interrogation of the device confirmed a probable lead fracture with immediate warning of high impedance in excess of 5000 ohms.She states that she is unsure how this happened although she reports having seizures in her sleep.The device was turned off.The patient had a full replacement on (b)(6) 2016.The explanted devices have not been received to date.

Event Description

The generator and lead were received for analysis on 06/02/2016.Product analysis for the lead was completed and approved on 06/23/2016.Note that a portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis the bilumen tubing appeared to be twisted, in several areas and the end appeared to be twisted / abraded open / torn.During the visual analysis the connector pin tri-filar coil appeared to be broken in two areas.Scanning electron microscopy was performed on the connector pin tri-filar coil break as having evidence of a stress induced fracture (rotational forces) which most likely completed the fracture with mechanical damage.The area on another broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture.The area on the last broken coil strand was identified as having what appeared to be evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and residual material.Scanning electron microscopy was performed on the connector ring tri-filar coil break and identified the area on one of the broken coil strands as being mechanically damaged (smooth surfaces) with pitting which prevented identification of the coil fracture type.The area on the remaining broken coil strands was identified as having evidence of a stress induced fracture (rotational forces) which most likely completed the fracture with mechanical damage on both and pitting on one of the broken coil strands.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.The abraded openings / torn area found on the bilumen tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the bilumen tubing.With the exception of the observed discontinuities and abraded opening 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 setscrew 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 portions were performed, during the visual analysis, with no discontinuities identified.Product analysis for the generator was completed and approved on 06/27/2016.The returned decoder shows that the ¿diagvinitialprechange¿ value is 4523 ohms while the ¿diagvinitialpostchange¿ value is 13568 ohms, and the time of change detection (b)(6) 2016 (explant (b)(6) 2016).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 addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.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.The pulse generator diagnostics were as expected for the programmed parameters.In addition, 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 303
• 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: 5624728
• MDR Text Key: 44911661
• Report Number: 1644487-2016-00934
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: 303-20
• Device Lot Number: 202132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2012
• 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: 39 YR