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

Model Number 302-20

Device Problems Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 06/01/2017

Event Type  malfunction  

Event Description

It was reported that high lead impedance was discovered on the patient's vns system.Surgery to replace the vns lead was completed.The explanted lead has not been received by the manufacturer to date.No additional pertinent information has been received to date.

Event Description

The explanted lead was received by the manufacturer, but analysis has not been approved to date.No additional relevant information has been received to date.

Event Description

Analysis was approved for the explanted lead on (b)(6) 2017.The coil of the connector ring appeared to be broken in several locations along the lead.Microscopy identified the break to show evidence of a stress induced fracture with mechanical damage due to fatigue, pitting, and a stress induced fracture due to rotational forces.Mechanical damage in some places prevented the fracture type from being identified.Abraded openings were observed on the outer and inner silicone tubes in several locations that likely contributed to the dried fluid remnants found inside the lead insulation.The set screw 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.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: 6686296
• MDR Text Key: 79059771
• Report Number: 1644487-2017-04094
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/15/2017

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: 02/29/2016
• Device Model Number: 302-20
• Device Lot Number: 202073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 07/10/2017; 08/21/2017
• Supplement Dates FDA Received: 08/04/2017; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2012
• 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 Age: 58 YR