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

Model Number 304-20

Device Problems Break (1069); Corroded (1131); Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Stretched (1601); Material Twisted/Bent (2981)

Patient Problems Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2016

Event Type  malfunction  

Event Description

On (b)(6) 2016 it was reported that the patient was scheduled for surgery on (b)(6) 2016 but had to cancel due to an issue with one of her leads.It was stated that an x-ray was completed a week prior and the lead was found to be broken so they will reschedule the surgery for a full revision.Clinic notes dated (b)(6) 2016 contain an x-ray review.The x-ray report states that the battery and lead are observed in the left anterior chest and neck (respectively) and that the ¿connection between the battery pack and cervical leads appears discontinuous when compared to the prior study¿.It was stated that the lead is stretched and twisted.The surgeon suspects the patient may have been manipulating the device in the pocket.No surgical intervention has occurred to date.

Event Description

The patient reported that she had an hour long seizure on (b)(6) 2017 and was scheduled for full revision surgery.The patient's generator was also depleted, so the seizure may have been due to the loss of therapy from normal battery depletion.The reported high impedance may be related to the migration of the patient's vns reported in mfr.Report #1644487-2013-03491.The patient reported she had a ct scan of the neck and was told that the lead was fine.However, the patient later had full revision surgery, and x-rays were performed during the surgery.The x-ray showed that the lead was twisted, most likely due to patient manipulation.The explanted generator and lead have not been received to date.

Event Description

The explanted generator and lead were received, but analysis has not been approved to date.

Event Description

Analysis was approved for the generator.An open can measurement of the battery voltage determined that the battery was depleted.Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition.The device performed according to functional specifications.Therefore, the electrical performance of the generator was used to conclude that no abnormal performance or any other type of adverse condition was found with the generator.Analysis was also approved for the lead.Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis, a portion of the lead assembly (body) appeared to be twisted and compressed.During the visual analysis the connector ring quadfilar coil appeared to be broken, and the connector pin quadfilar coil also appeared to be broken.Scanning electron microscopy was performed on the connector ring quadfilar coil break and identified the area as having extensive pitting, which prevented identification of the coil fracture type.Pitting and residual material were observed on the coil surface.Scanning electron microscopy was performed on the connector pin quadfilar coil break and identified the area as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type with pitting on one.Pitting and residual material were 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 found on the outer silicone tubing and abraded opening found on one of the inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and one inner silicone tubing.With the exception of the observed discontinuities and abraded openings, the condition of the returned lead portions was 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 provided evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, and no other discontinuities were identified.

• 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: 6149001
• MDR Text Key: 62136589
• Report Number: 1644487-2016-02800
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Model Number: 304-20
• Device Lot Number: 3215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2011
• 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: 30 YR