MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Break (1069); Stretched (1601); Material Distortion (2977); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

It was reported by the surgeon that during lead replacement surgery, the vns patient¿s generator appeared twisted and that the generator header was damaged.The vns generator and lead appeared distorted and stretched.The generator was explanted and replaced during the procedure.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.The reason for lead revision is captured in manufacturer report # 1644487-2014-00435.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

• Brand Name: PULSE GEN MODEL 103
• 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: 3746607
• MDR Text Key: 4479964
• Report Number: 1644487-2014-00943
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: 103
• Device Lot Number: 201930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2011
• 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 Age: 18 YR