MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Chest Pain (1776); Dyspnea (1816); Twiddlers Syndrome (2114); Neck Pain (2433)

Event Date 10/16/2016

Event Type  Injury  

Event Description

It was reported the patient was having some pain in her neck and chest, she was coughing a lot, and had shortness of breath.These symptoms were explained to be associated with stimulation.Diagnostics showed the device was working as intended and showed dcdc = 2, which is within normal limits.It was also noted the patient was laying tiles and may have injured the area of the device and was having pain at the generator site, but it was also noted that the patient tried to restrain her son who pulled at hear vns implant site.The patient became concerned that the device was damaged and noted that she can visualize the lead body.X-rays were taken, but it was noted by the physician that there was nothing out of the ordinary observed.The patient had her generator replaced on (b)(6) 2013 as it was noted the generator had migrated, and since the generator had been implanted for a few years, they decided to go ahead and replace the generator during the repositioning surgery.It was noted the generator was discarded after surgery.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6098307
• MDR Text Key: 59770940
• Report Number: 1644487-2016-02632
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2015
• Device Model Number: 102
• Device Lot Number: 202460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 41 YR