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

Model Number 102

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Chest Pain (1776)

Event Date 07/27/2013

Event Type  Injury  

Event Description

It was reported that the patient was experiencing chest pain and underwent device explant.It was also reported that the patient did not experience efficacy with vns therapy.It was reported that the patient's device was programmed off on (b)(6) 2013.Device diagnostics were within normal limits.It was reported that the patient had complained of chest pain that had been occurring for 3 days.The patient noted significant relief from the chest pain when the device was programmed off.It was also reported that clinic notes dated (b)(6) 2013 noted migration of the device and because of the patient's chest pain the patient was referred for surgery because the neurologist thought there may be an issue with the device.It was noted that the patient was seizure free since the device was programmed off so the patient's family asked for device explant with no plans to reimplant.The explanted generator and lead were received for analysis.Analysis of the lead was completed on (b)(4) 2014.Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.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, and no discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints.Analysis of the generator was completed on (b)(4) 2014.The generator performed according to functional specifications.During the product analysis there were no anomalies found with the pulse generator.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 102
• 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: 4055314
• MDR Text Key: 21523491
• Report Number: 1644487-2014-02181
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2010
• Device Model Number: 102
• Device Lot Number: 2177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Event Location: Other
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2008
• 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: 19 YR