MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Tissue Breakdown (2681); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that a vns patient underwent full explant surgery on (b)(6) 2016.It was reported by the nurse that the system was explanted because "the generator began to erode through the patient's skin".It was reported that the patient will be implanted again in 3 to 6 months when the infection has totally cleared.It was reported that the lead impedance value before the surgery was 2859 ohms.Review of manufacturing records confirmed sterilization for the generator prior to distribution.Additional information was received from the nurse, indicating that there was a vertical wound in the chest and there was protrusion of the generator which, when reviewed by the neurosurgeon and the pus removed, the generator was apparently visible.It was reported that when the nurse saw the patient on (b)(6) 2016, nothing was mentioned about the generator site; so the event started between (b)(6) 2016.No patient trauma or manipulation occurred that could be the cause of that event.Migration of the generator was reported, by the nurse, to be possible because the generator appeared to have moved nearer to the skin.The return of the explanted device is expected but it has not been received to date.

Event Description

The explanted generator and lead were returned to the manufacturer on 10/10/2016.An analysis of the returned generator is underway but it has not been completed to date.An analysis of the returned lead was completed and the lead analysis results were submitted to the fda via the medwatch report # 1644487-2016-02457.

Event Description

Analysis of the explanted generator was completed and the pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery shows an ifi=no condition.The data in the diagaccumconsumed memory locations revealed that 10.467% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

It was reported that the patient underwent surgery to have a new lead and generator implanted.The remaining portion of the lead was explanted during the procedure.The explanted lead portion was received and will undergo product analysis.However the analysis will not be reported in this report but rather in mfg.Report # 1644487-2016-02457.

• Brand Name: PULSE GEN MODEL 105
• 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: 5959374
• MDR Text Key: 55003685
• Report Number: 1644487-2016-02117
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 105
• Device Lot Number: 203087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2014
• 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: 37 YR