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

Model Number 105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 05/13/2014

Event Type  Injury  

Event Description

Analysis of the explanted generator and lead was completed.There were no adverse functional, mechanical, or visual issues identified with the returned generator.Analysis of the lead found abraded openings on the outer silicone tubing, 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.Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device.Note that since a large portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description

It was reported that the vns patient underwent surgery on (b)(6) 2014 to explant her generator and lead.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.Further follow-up revealed that the patient¿s device had to be explanted due to generator and lead extrusion.The patient had been picking at her devices which caused them to extrude inferiorly and laterally to the original incision sites.The patient went to the er on (b)(6) 2014 due to device extrusion at the axillary incision site.Prior to explant, there was a noticeable breakdown of the patient¿s skin due to the extrusion.There were no signs of infection or abscess, but the patient was antibiotics as a precaution.The patient is expected to be re-implanted once her incision sites are healed.The patient has not been re-implanted to date.

• 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: 3894796
• MDR Text Key: 4749776
• Report Number: 1644487-2014-01588
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2014
• Device Model Number: 105
• Device Lot Number: 3398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2012
• 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: 52 YR