MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER; MODEL 250

Model Number MODEL 250

Device Problem Device Inoperable (1663)

Patient Problem Pain (1994)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

The patient underwent generator replacement.It was reported that the patient is no longer experiencing pain.The explanted generator is expected to be returned for analysis, but has not been received to date.

Event Description

The explanted generator was returned for product analysis.The analysis found that the generator performed according to functional specifications with no anomalies found.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified and the device had not reached eri or eos.The pulse generator diagnostics were as expected for the programmed parameters.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.Visual examination noted tool marks/dents on the pulse generator case.The header had tool marks on it.The marks are most likely associated with manipulation of the device during the explant procedure as the markings are consistent with devices typically used in a surgical procedure (forceps, etc.).Signs of discoloration are evident on the pulse generator case, which is consistent with the adhered remnants of dried body fluids following an explant process.

Event Description

It was reported that the patient complained of intermittent pain at the generator site.The physician believes that the generator was depleting or nearing end of service and referred the patient for generator replacement.No additional relevant information will be provided due to hippa policy at the facility.No known surgical interventions have been performed to date.

Event Description

During review of the in-house programming/diagnostic history database, it was observed that during the office visit on (b)(6) 2015 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2009.The generator was found to be programmed off and the settings found were indicative of a faulted diagnostic test however the database did not contain a faulted test.There was a gap in history from (b)(6) 2009-(b)(6) 2015 and due to this gap it is not known how long the generator was programmed off.The generator was then programmed on and the patient reported painful stimulation.The generator was then programmed off again in response to the painful stimulation.It appears that the patient's reported painful stimulation that is related to the device being programmed off for an undetermined amount of time and then being programmed back on.No additional relevant information has been received to date.

• Brand Name: PROGRAMMING COMPUTER
• Type of Device: MODEL 250
• 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: 4577713
• MDR Text Key: 18713805
• Report Number: 1644487-2015-04079
• Device Sequence Number: 1
• Product Code: MUZ
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2008
• Device Model Number: MODEL 250
• Device Lot Number: 015950
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/17/2015; 07/13/2015; 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2006
• 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: 61 YR