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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2013

Event Type  malfunction  

Event Description

The patient underwent generator and lead replacement.The lead and generator were received for analysis.Analysis is underway, but has not been completed to date.

Event Description

High lead impedance was observed during a follow-up appointment for the patient on (b)(6) 2013.The physician performed system diagnostics several times at different angles.Two of the diagnostics showed normal results; however, after this the rest of the diagnostics showed high lead impedance.The vns device was disabled (programmed off to 0ma).The physician plans to proceed with a "wait-and-see" approach.Ap and lateral chest and neck x-rays were sent to the manufacturer for review.Based on the images provided, the generator appears to be placed in a normal orientation in the left chest.It appears that the lead pin is fully inserted into the connector block.The filter feed-thru wires appear to be intact.The lead wires appear to be intact at the connector pin, and a portion of the lead wire appears to be located behind the generator so it could not be assessed.The electrodes were visualized in the neck and appear in the proper orientation.There appears to be a strain relief bend present, but no strain relief loop appears to be present.There appears to be 3 tie-downs present.The first two tie-downs appear to be placed per labeling as they are placed parallel to the electrodes.The third tie-down does not appear to be placed per labeling given a lack of a strain relief loop.There does not appear to be any gross discontinuities or sharp angles in the lead.However, due to the image quality and the images provided, the entire lead body and generator could not be fully assessed.Follow up with the physician found that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance event.The patient has returned to his country where he will consult with another physician on replacement of the device.Surgery is likely, but has not occurred to date.No other information has been provided.

Manufacturer Narrative

Analysis of programming history.

Manufacturer Narrative

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

Event Description

Analysis of the generator was completed on 01/16/2015.Electrical test results showed that the pulse generator performed according to functional specifications.There were no adverse functional, mechanical, or visual issues identified with the returned generator.Analysis of the lead was completed on 01/25/2015.Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis of the returned 408mm portion the (-) connector pin and the (+) connector ring quadfilar coils appeared to be broken approximately 325mm from the end of the connector boot.Scanning electron microscopy was performed on the connector end of the (-) connector pin quadfilar coil break (found at 325mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting on two of the broken coil strands.Scanning electron microscopy was performed on the electrode (mating) end of the (-) connector pin quadfilar coil break (found at 325mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting.Pitting was observed on the coil surface.Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 325mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type.Pitting was observed on three of the broken coil strands.Evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on one of the broken coils strands.Pitting was observed on the coil surface.Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 325mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type, with pitting on two of the broken coil strands.The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting.During the visual analysis of the returned 408mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 334mm from the end of the connector boot.Scanning electron microscopy was performed on the connector end and electrode (mating) end of the (+) connector ring quadfilar coil break (found at 334mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting.The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting.What appeared to be melting 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.What appeared to be residual material was observed in various locations.The abraded opening 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 discontinuities, 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.

• 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: 3576626
• MDR Text Key: 5277477
• Report Number: 1644487-2014-00240
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2013

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: 12/31/2014
• Device Model Number: 302-20
• Device Lot Number: 2895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/16/2015
• Initial Date FDA Received: 01/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2015; 02/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2010
• 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: 25 YR