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

Model Number 103

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 08/28/2014

Event Type  malfunction  

Event Description

During a repositioning surgery a recently implanted generator was found to be at end of service.It is believed that electorcaudary was used during the surgery and caused the end of service condition.The generator was replaced that day as a result.Attempts for additional information have been unsuccessful.The repositioning surgery and the events leading to it will be reported on medwatch 1644487-2014-02493.

Event Description

It was reported that the generator was discarded during surgery; therefore, no product analysis can be performed.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Model #, serial #, lot#, expiration date; corrected data: previously submitted mdr inadvertently provided product information that was incorrect.Device manufacture date; corrected data: previously submitted mdr inadvertently provided product information that was incorrect.

• Brand Name: PULSE GEN MODEL 103
• 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: 4121637
• MDR Text Key: 4942743
• Report Number: 1644487-2014-02494
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2015
• Device Model Number: 103
• Device Lot Number: 3781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2013
• 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: 34 YR