MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Seizures (2063)

Event Date 04/14/2014

Event Type  Injury  

Event Description

It was reported that the vns patient had an open wound at his neck incision site.Granulation tissue was observed eight months after implant and the open wound was first observed on (b)(6) 2014.The surgeon stated that there was no obvious reason for the granulation tissue.Debridement of the granulation tissue was performed.The surgeon stated that trauma possibly had caused or contributed to the event as the patient had seizures and hit the affected areas.No causal or contributor medication changes preceded the onset of the event.Further follow-up revealed that the patient was given antibiotics and the patient¿s issues resolved.The patient¿s issues came back and the surgeon stated that the device needed to be explanted due to abscesses at the lead site.No known surgical interventions have occurred to date.

Event Description

On (b)(6) 2014 product analysis was completed on the explanted generator.Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab.The battery voltage was 2.995 volts (not at ifi), as measured during completion of the final electrical test.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.Product analysis on the lead was completed on (b)(6) 2014.Other than the typical wear and explant related observations, no anomalies were identified in the returned lead.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description

Additional information was received stating that the vns patient developed another pustule at his neck incision site.The surgeon previously packed the wound and the granulation tissue appeared to resolve by (b)(6) 2014.However, granulation tissue was noted at the same site during an office visit on (b)(6) 2014.The surgeon speculated that an infection had developed or the patient¿s body was rejecting the device.Cultures showed moderate staph.The patient underwent surgery on (b)(6) 2014 to explant his generator and lead.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

• Brand Name: LEAD MODEL 303
• 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: 3864292
• MDR Text Key: 4590693
• Report Number: 1644487-2014-01461
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: 303-20
• Device Lot Number: 202391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 35 YR