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

Model Number 304-20

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Fracture (1260)

Patient Problems Fall (1848); Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 01/01/2016

Event Type  malfunction  

Event Description

It was reported that the patient was having generator replacement due to neos, which became a full revision when a lead fracture was found.The surgeon said he did not cut the lead.It was reported that the patient had fallen some time ago (specific date unknown).The surgeon reported the patient was also experiencing an increase in seizures recently, which he believed may be due to the lead break.The device was interrogated during surgery, but no diagnostics could be run.A company representative stated this was because the device was actually eos pulse disabled, not neos.The programming tablet and wand were confirmed to be functioning.The explanted lead and generator was received on 11/08/2016.Analysis is underway, but hasn't been completed to date.Per a return product form, the adverse event listed stated "lead was off generator in the pocket." no additional relevant information has been received to date.

Event Description

Per company representative, the statement the lead was not attached to its end in the generator header during the surgery.The lead being off the generator likely refers to the discontinuity in the lead.Analysis was performed on the returned generator.An end-of-service warning message was verified during analysis and found to be associated with the output being disabled by the pulse generator.Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant.The generator was most likely at a near end of service state and the high energy exposure resulted in further energy depletion from the battery.This resulted in the observed ¿pulse-disable¿ condition.During analysis, the pulse generator would not interrogate (with a space of 0.0 inches between the pulse generator and the programming wand).With the pulse generator case removed and the battery still attached to the printed circuit board assembly (pcba), the battery measured 1.640 volts, confirming an eos condition.The data revealed that 113.225% of the battery had been consumed.The electrical test results show that the pcba performs according to functional specifications, except that the c4 capacitor is out of specification.This condition does not indicate a failure of the device or the component, and is not expected to have an adverse effect on battery longevity.There were no additional performance or any other type of adverse conditions found with the pulse generator.Analysis performed on the returned lead identified a break in the positive and the negative lead coils.The appearance of the lead suggests patient manipulation of the implanted device.Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) has occurred on the lead coils.The exact point in time of when it occurred is unknown.Also, secondary stress-fissures were noted in the vicinity of the broken strands.A cut in the outer silicone tubing was noted.Abrasions were noted on the outer silicone tubing at multiple locations.Organic matter covered the inside and outside of the coil ends at the lead break site.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner silicone tubing.No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portions.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

• 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: 6121868
• MDR Text Key: 61021248
• Report Number: 1644487-2016-02713
• 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
• Report Date: 01/03/2017

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: 02/29/2016
• Device Model Number: 304-20
• Device Lot Number: 2020201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2012
• 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: 20 YR