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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

Per internal data obtained through product analysis from the explanted generator revealed that there was a change in impedance reading from 2209 ohms to 10000 ohms on approximately (b)(6) 2014.

Event Description

It was initially reported that the patient had high impedance.The patient had their generator turned off and was schedule for surgery.The patient had a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation.Product analysis is planned, but has not been completed.

Manufacturer Narrative

Manufacturer Narrative

Date of event, corrected data: the supplemental report #1 inadvertently did not report this data.Describe event or problem, corrected data: the supplemental report #1 inadvertently did not report this data.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description

Additional information was received that product analysis was completed on the generator and lead.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 2.941 volts as measured shows an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 57.124% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.Note that a portion of the (-) green electrode quadfilar coil was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis of the returned 455mm portion the end of the (-) connector pin quadfilar coil appeared to be broken at the distal end of the anchor tether.Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting.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 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.With the exception of the observed discontinuity the condition of the returned lead portions 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, and no other discontinuities were identified.Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegation of 'fracture of 'high impedance' note that since a portion of the (-) green electrode quadfilar coil was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4201473
• MDR Text Key: 5104646
• Report Number: 1644487-2014-02830
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 10/27/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/07/2014; 11/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2008
• 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: 47 YR