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

Model Number 103

Device Problem Premature End-of-Life Indicator (1480)

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

Event Date 11/07/2016

Event Type  malfunction  

Event Description

Around a month after a repositioning due to migration of the patient's generator, captured in mfr.Report # 1644487-2016-02776, a company representative interrogated the patient's device and noted it was pulse-disabled even though the battery icon showed full charge.System diagnostics confirmed device function.The device was able to be programmed back on.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Manufacturer Narrative

Evaluation codes (refer to coding manual), corrected data: results code was inadvertently reported in the initial mdr.Results code was inadvertently excluded from the initial mdr.

Event Description

It was reported by the surgeon's office that electrocautery was not used during the repositioning surgery reported in mfr.Report # 1644487-2016-02776.They indicated that they were able to interrogate the generator after the surgery.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

Additional programming history was reviewed from the date of the repositioning surgery.The internal data of the generator revealed that the patient's generator was pulse-disabled on the date of surgery.The information also revealed that the generator's voltage dropped sharply within two hours on the date of surgery.This drop in voltage into pulse-disabled status is consistent with the behavior of generators exposed to electrostatic discharge during the repositioning surgery reported in mfr.Report #1644487-2017-03249.Possible sources of electrostatic discharge during a repositioning surgery would be use of electrocautery around the generator or electrostatic discharge through the torque wrench.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

• 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: 6255218
• MDR Text Key: 64926256
• Report Number: 1644487-2017-03015
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2015
• Device Model Number: 103
• Device Lot Number: 202502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2013
• 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: 29 YR