MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Device Expiration Issue (1216); Low impedance (2285); Low Battery (2584); Material Twisted/Bent (2981)

Patient Problems Seizures (2063); Therapeutic Effects, Unexpected (2099)

Event Date 01/01/2012

Event Type  malfunction  

Manufacturer Narrative

Event Description

From clinic notes, it was reported the patient's battery was at near end of service and the patient was being referred for replacement.The physician also noted an increase in seizures and attributed the recent increase in patient seizures to the battery being at near end of service.Prior to the surgery, the patient's father stated he did not think the generator had been working, as he had also noted an increase in seizures for his son in the last 3-4 years.Additional information from the livanova case manager indicated the patient went in for generator replacement on (b)(6) 2016, but the surgery turned into a full replacement of the generator and the lead when low impedance and a compromised lead were discovered.During the revision, low impedance was discovered through indication from the new device being implanted.The physician visualized the lead and noticed it was all very twisted as though someone had been twisting it around for years.A review of the programming history data revealed dcdc code of 0 on (b)(6) 2007.A dcdc code of 0 can be observed for both normal impedance and for low impedance.Therefore it is possible that the low impedance may have present for some time prior to the surgery.The implant facility discarded the generator, and the lead has not been received to date.

Event Description

The lead was received on 10/26/2016 and product analysis was performed.The electrodes were not returned, therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis the quadfilar coils appeared to be stretched, wavy and spiraled, in some areas and a portion of the returned lead assembly appeared to be twisted and spiraled.During the visual analysis the connector pin and connector ring quadfilar coils appeared to be twisted together.Scanning electron microscopy was performed and the area was identified as having evidence of a stress induced fracture (rotational forces) which most likely completed the fracture with mechanical damage and no pitting.It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces.The abraded opening and slice mark 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 and calcium.Refer to attached eds sheet for additional information.With the exception of the twisted condition of the returned lead portion 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 portion were performed, during the visual analysis, and no discontinuities were identified.

Manufacturer Narrative

Analysis results.Previous supplemental mdr #1 inadvertently did not include the full analysis results, which were completed on 10/26/2016.

Event Description

Analysis of the returned lead showed that both the inner and outer tubing were twisted/torn.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 6024741
• MDR Text Key: 57325298
• Report Number: 1644487-2016-02343
• 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: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2009
• Device Model Number: 302-20
• Device Lot Number: 1547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2006
• 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): Other
• Patient Age: 11 YR