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

Model Number 106

Device Problem Extrusion (2934)

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

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had been picking at the incision site following lead and generator implant surgery which led to an infection and the generator extruding.As a result the patient was hospitalized and the generator was explanted and not replaced.The lead was left implanted.The patient was given antibiotics and referred back to her neurologist.A review of manufacturing records of the lead and generator found that both devices were sterilized prior to distribution.Attempts for additional relevant information have not been received to date.No additional surgical interventions are known to have occurred to date.

Event Description

It was reported that the device was discarded after explant.A surgical consult is planned to discuss re-implantation of the generator.

Manufacturer Narrative

Corrected data: describe event or problem; this information was inadvertently left off on mfg.Report #1.Corrected data: date received by manufacturer ; this information was inadvertently reported as 06/28/2016 on mfg.Report #1, it should have been reported as 06/23/2016.

Event Description

It was reported that two days after vns lead and generator implant surgery, the patient collapsed due to cardiac arrest.She was transported to the hospital where she placed on a respirator when it was determined that she had aspiration pneumonia.The patient remained hospitalized for 13 days due to this event.Three days after discharge the patient was admitted again to the hospital for infection at the vns incision site.The physician stated that a relationship with the vns procedure to the cardiac event secondary to aspiration pneumonia could not be determined due to the patient not exhibiting symptoms at the time of the vns implant procedure.It is likely that the cardiac arrest secondary to aspiration pneumonia weakened the patient's medical state which contributed to the patient developing the infection.

Event Description

It was reported that during the patient's hospitalization due to cardiac arrest secondary to aspiration pneumonia the patient was experiencing hypoxia.

Event Description

If/when the patient is re-implanted in the future, this will not be reported since it will not be related to the initial infection and aspiration pneumonia events.

• 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: 5749719
• MDR Text Key: 48191671
• Report Number: 1644487-2016-01428
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/31/2016

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: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: 106
• Device Lot Number: 4671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/31/2016
• Initial Date FDA Received: 06/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/09/2016; 07/18/2016; 07/19/2016; 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2016
• 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: 23 YR