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

Model Number 105

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problems Seizures, Grand-Mal (2168); Seizures, Absence (2261); Shock from Patient Lead(s) (3162)

Event Date 02/25/2014

Event Type  Injury  

Event Description

Clinic notes were received for the vns patient¿s neurosurgery consultation on (b)(6) 2014.The notes indicate that the patient was experiencing a recent increase in seizures along with a shocking sensation at the generator site; therefore, the patient was admitted to the hospital through the emergency room on (b)(6) 2014.The patient stated that his seizure frequency had increased from five seizures a day to a seizure every hour.The baseline seizures appeared to last approximately 15 seconds and were tonic-clonic or absence seizures.Radiology reported that neck x-rays showed that lead wires were ¿off.¿ chest x-rays were reported to be unremarkable.Operative notes were received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014.The notes indicate that the patient was experiencing a shocking sensation in his neck with stimulation.Imaging revealed abnormal placement of the lead electrodes.The generator was replaced during the procedure as it was nearing end of service.An implant card was received stating that the lead was replaced due to lead discontinuity.Diagnostic results with the replacement generator and lead revealed lead impedance within normal limits (impedance value ¿ 1906 ohms).Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.Attempts for additional relevant information were made, but have been unsuccessful to date.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Event Description

Analysis of the returned generator and lead was completed.Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.Review of the as-received internal device data showed high impedance never occurred.Analysis of the returned lead portion found abraded openings on the outer silicone tubing which most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints.Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.

Manufacturer Narrative

Review of the available programming and diagnostic history.Device failure is suspected, but did not cause or contribute to a death.

Manufacturer Narrative

Adverse event and/or product problem; corrected data: additional information indicates that a device malfunction did not occur.Brand name; corrected data: additional information indicates that the suspect device is the generator.Type of device, name; corrected data: additional information indicates that the suspect device is the generator.Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the generator.Date of implant; corrected data: additional information indicates that the suspect device is the generator.Type of reportable event; corrected data: additional information indicates that a device malfunction did not occur.Device manufacture date; corrected data: additional information indicates that the suspect device is the generator.

• Brand Name: PULSE GEN MODEL 105
• 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: 3701858
• MDR Text Key: 4231763
• Report Number: 1644487-2014-00776
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/25/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2014
• Device Model Number: 105
• Device Lot Number: 202126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 03/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2012
• 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: 14 YR