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

Model Number 103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 06/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient's generator showed neos-yes.The device was recently implanted on (b)(6) 2015.The patient had scheduled surgery on (b)(6) 2015 due to events reported in mfg report #: 1644487-2015-05282.The surgeon for the surgery on (b)(6) 2015 felt that the generator was most likely depleted due to electrocautery coming into contact with the generator during implant.The generator was replaced on (b)(6) 2015.The explanted product has not been received by the manufacturer for analysis to date.Good faith attempts for additional, relevant information have been unsuccessful to date.

Event Description

The patient had surgery on (b)(6) 2015 due to high impedance, as captured in mfg report #: 1644487-2015-05282.The generator was reported to have shown end of service pulse disabled message on that date.As a result, the generator was replaced on (b)(6) 2015.It was reported that the generator showed near end of service upon system diagnostics, and the surgeon felt that this was most likely depleted due to electrocautery coming into contact with the generator during implant.No additional relevant information has been received to date.

Event Description

It was reported that the explanted device is not being returned to the manufacturer per hospital policy.As a result, analysis is unable to be performed.

• 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: 4936810
• MDR Text Key: 22833777
• Report Number: 1644487-2015-05312
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/03/2016
• Device Model Number: 103
• Device Lot Number: 4089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2014
• 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: 49 YR