MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Failure to Anastomose (1028); Unspecified Infection (1930)

Event Date 06/16/2014

Event Type  Injury  

Event Description

It was reported that the vns study patient developed an infection on (b)(6) 2014 at the incision site.Furthermore, the patient¿s incision site reportedly had opened.The infection was attributed to the vns implant surgery.The patient was hospitalized from (b)(6) 2014.The patient underwent surgery on (b)(6) 2014 to explant the generator and lead.

Manufacturer Narrative

Pt age at time of event: the previously submitted mdr inadvertently provided an incorrect age at time of event and date of birth for the patient.Pt gender: the previously submitted mdr inadvertently provided an incorrect sex for the patient.Operator of device; corrected data: the previously submitted mdr inadvertently provided the wrong device operator for the event.

Event Description

Further information indicated that the event ended on (b)(6) 2014.The patient recovered.Review of manufacturing records confirmed sterilization for the generator prior to distribution.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• 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: 3987355
• MDR Text Key: 21489001
• Report Number: 1644487-2014-01961
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: 102
• Device Lot Number: 202614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2013
• 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: 27 YR