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 06/29/2016

Event Type  malfunction  

Event Description

It was reported that a patient was referred for full revision surgery due to high impedance.The physician reported that x-rays showed a lead fracture on (b)(6) 2016.The cause of the high impedance/lead fracture was unknown.The patient had full revision surgery on (b)(6) 2016.The explanted generator and lead were received on 08/23/2016.The generator evaluation will be reported in mfr.Report #1644487-2016-01943 for possible premature battery depletion.Analysis of the lead has not been approved to date.

Event Description

Analysis of the lead was approved on 09/02/2016.Note that a portion of the lead assembly was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.Multiple breaks were identified in the quadfilar coil, and extensive pitting was present.The pitting prevented identification of the coil fracture type of one of the breaks.Another break was identified to be due to mechanical damaged with pitting, and it was believed that stimulation was present for a certain period of time.The abraded openings found on the outer silicone tubing, connector ring inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and connector ring inner 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
• 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: 5909500
• MDR Text Key: 54064599
• Report Number: 1644487-2016-01942
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/02/2016

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: 04/30/2010
• Device Model Number: 302-20
• Device Lot Number: 200485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2007
• 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: 12 YR