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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/15/2014

Event Type  Injury  

Event Description

It was reported that the vns patient developed an infection following a recent generator replacement surgery on (b)(6) 2014.The patient was given additional antibiotic medication.No known surgical interventions have occurred to date.Review of manufacturing records confirmed sterilization for the generator prior to distribution.

Event Description

It was reported that the patient had explant surgery on (b)(6) 2015.The generator and lead were explanted due to wound infection.

Event Description

It was reported that re-implant is not being pursued at this time.The physician believes the patient¿s constant scratching at the sites would result in infection occurring again in the future.

Event Description

It was reported by the treating physician¿s office that the patient¿s caregiver would not leave the wound alone and subsequently caused the infection.Analysis of the generator was completed.There were no performance or any other type of adverse conditions found with the pulse generator.Except for an abraded opening in the outer tubing, there were no observed product related issues with the returned lead portions.Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the coil end.The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant and therefore delivering therapy to the cut leads.Analysis of the lead revealed dried remnants of what appear to have been fluids/betadine solution inside the inner and outer silicone tubing.No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion.Note that since a portion of the lead (including the electrode array) 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.

Event Description

Although reimplant may occur, it has not occurred to date.

Event Description

The patient¿s infected area has still failed to heal completely.The patient will be treated with antibiotic ointment.The electrode portion of the lead was removed on (b)(6) 2015 since the wound was not healing.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer device history records were reviewed.Review of manufacturing records confirmed sterilization for the lead prior to distribution.

Manufacturer Narrative

Device available for evaluation, corrected data: the supplemental report #1 inadvertently did not report this data.

• Brand Name: PULSE GEN MODEL 102
• 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: 4293846
• MDR Text Key: 5269619
• Report Number: 1644487-2014-03190
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/03/2014

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: 12/31/2015
• Device Model Number: 102
• Device Lot Number: 202816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 12/03/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/20/2015; 02/18/2015; 02/27/2015; 03/30/2015; 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2014
• 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: 15 YR