MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Date 11/14/2013

Event Type  Injury  

Event Description

It was reported that the vns patient developed an infection and subsequently underwent surgery to explant the device.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.The patient has not been re-implanted to date.

Event Description

Additional information was received regarding the infection.In the month of (b)(6) 2014, a follow up appointment showed a dehiscent wound and infectious secretions.The culture showed e.Coli.Patient was admitted (b)(6) 2014.Patient's generator was explanted on (b)(6) 2014 and patient was discharged on (b)(6) 2014.Patient was readmitted (b)(6) 2014 due to secretions from the wound and extrusion of the electrode from the chest site, for which he was hospitalized and explanted partially on (b)(6) 2014.Culture showed staphylococcus aureus.He was kept in the hospital to receive antibiotic therapy.The explanted generator was returned on (b)(4) 2015.Analysis is underway but has not been completed.

Manufacturer Narrative

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

Event Description

Analysis of the generator showed that the pulse generator performed according to functional specifications.The battery shows an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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: 4347863
• MDR Text Key: 5174715
• Report Number: 1644487-2014-03423
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: VE
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: 103
• Device Lot Number: 3750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2013
• 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: 21 YR