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

Model Number 302-20

Device Problems High impedance (1291); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bruise/Contusion (1754); Fall (1848); Seizures (2063)

Event Date 03/10/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms) during an office visit on (b)(6) 2014.The patient stated that she had a seizure and fell.The patient¿s arm was bruised but she is unsure if the fall caused or contributed to the reported high impedance.Additional information was received stating that the patient underwent generator and lead replacement surgery due to high impedance on (b)(6) 2014.The explanted products have not been returned to manufacturer to date.

Event Description

The explanted generator and lead were returned for analysis.Analysis of the lead was completed on (b)(4) 2014.Scanning electron microscopy images of the positive coil show that pitting or electro¿etching conditions have occurred at the end of the positive coil.Due to metal dissolution the fracture mechanism of the coil cannot be determined.Scanning electron microscopy images of the negative coil show that a stress-induced fracture (due to rotational forces) has occurred on the negative coil.Also, the early stages of secondary fractures noted in the vicinity of the broken strands appear to indicate the stress-related primary fractures were most likely created during the explant procedure.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.Analysis of the generator was completed on (b)(4) 2014.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

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

• 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: 3723807
• MDR Text Key: 4306657
• Report Number: 1644487-2014-00870
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/10/2014

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: 06/30/2006
• Device Model Number: 302-20
• Device Lot Number: 010763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2004
• 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: 43 YR