MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Pain (1994); Seizures (2063)

Event Date 06/23/2015

Event Type  Injury  

Event Description

It was reported that the vns patient was experiencing an increase in seizures and painful stimulation.Follow-up revealed that the patient visited the office on (b)(6) 2015 due to painful stimulation in her neck.The physician decreased the device output current from 1.5ma to 0.25 ma and the patient subsequently began having an increased seizures during the visit.The physician reprogrammed the output current back up to the original settings and believed that this would resolve the patient¿s issues.

• Brand Name: PULSE GEN MODEL 105
• 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: 4922889
• MDR Text Key: 6435879
• Report Number: 1644487-2015-05227
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: 105
• Device Lot Number: 3688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR