MAUDE Adverse Event Report: CYBERONICS PROGRAMMING SOFTWARE

Model Number MODEL 250

Device Problems Use of Incorrect Control/Treatment Settings (1126); Programming Issue (3014)

Patient Problem No Code Available (3191)

Event Date 02/13/2009

Event Type  malfunction  

Event Description

During review of the patient¿s programming history available in the manufacturer¿s database, it was identified that a programming anomaly occurred.A system diagnostic test was performed, and a final interrogation was not performed and the patient left the visit.Manufacturer labeling indicates to perform a final interrogation to confirm intended settings prior to patients leaving the clinic.Upon initial interrogation on the subsequent visit, the device was at unintended settings.Settings were reprogrammed to intended settings on (b)(6) 2009.The magnet output current was left at 1.0 ma till device reached eos and was never corrected even though the patient was implanted with vns for depression.

Manufacturer Narrative

Analysis of programming history.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING SOFTWARE
• Manufacturer (Section D): CYBERONICS; 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: 4876825
• MDR Text Key: 6062580
• Report Number: 1644487-2015-05054
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2015

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 Model Number: MODEL 250
• Device Lot Number: 366994
• Other Device ID Number: VERSION 7.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR