MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Event Date 01/01/2011

Event Type  Injury  

Event Description

The patient reported that the lead would migrate and "block her throat" during her asthma attacks. Per the patient, this was preventing her from breathing. The patient did not know when the event started. At the time of this report, the patient also indicated that she did not experience efficacy from the device. The patient's vns system has since been explanted and the lead and generator have been returned to the manufacturer for product analysis. Analysis is not yet complete. It is unclear at this time, if the explant was performed for the reported migration or lack or efficacy. Attempts for additional information are underway.

Event Description

Additional information was obtained from the surgeon. He indicated that the patient was a non-responder to vns and he was unsure if the migration was occurring. There was no suspected manipulation or trauma. The physician indicated that the patient had extreme difficulty with her asthma when the device would stimulate but also stated that the surgery was performed for patient comfort.

Manufacturer Narrative

Event Description

Product analysis on the generator was completed on (b)(4) 2012. In the (b)(4) lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. 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. Product analysis on the explanted lead was also completed. An analysis was performed on the returned lead portion. Note that a portion 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. A puncture mark was observed on the outer silicone tubing. The mark penetrated the outer insulation and one inner silicone tubing. The quadfilar coil did not appear to be damaged. Slice marks were observed on the outer silicone tubing. The marks penetrated the outer and one inner silicone tubing and the quadfilar coil appeared to be kinked. The puncture and slices appeared to be made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities 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. Attempts for additional information have remained unsuccessful to date.

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: nydia grimes ; 100 cyberonics blvd; suite 600; houston , TX 77058 ; 2812287200
• MDR Report Key: 2351148
• Report Number: 1644487-2011-02869
• Device Sequence Number: 1
• Product Code: MUZ
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: PATIENT
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/29/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 10/31/2010
• Device MODEL Number: 302-20
• Device LOT Number: 200646
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 11/22/2011
• Is The Reporter A Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/10/2012
• Was Device Evaluated By Manufacturer?: Yes
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 11/29/2011 Patient Sequence Number: 1