MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Twiddlers Syndrome (2114)

Event Date 07/01/2015

Event Type  Injury  

Event Description

It was reported that the vns patient developed an infection at the generator site following prophylactic generator replacement surgery on (b)(6) 2015.The patient had been picking at the generator incision site and opened up the surgical wound after removing the glue and stitches.The patient was subsequently given antibiotics.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.It was noted that the patient also opened up the surgical wound after her previous generator replacement surgery on (b)(6) 2012.This event was reported in manufacturer report #1644487-2012-00547.

Manufacturer Narrative

(b)(4): device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

• Brand Name: PULSE GEN MODEL 106
• 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: 4903064
• MDR Text Key: 21800801
• Report Number: 1644487-2015-05129
• 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: Physician
• Type of Report: Initial
• Report Date: 07/07/2015

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: 04/16/2017
• Device Model Number: 106
• Device Lot Number: 4365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2015
• 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: 62 YR