MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Unspecified Infection (1930); Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 02/01/2014

Event Type  Injury  

Event Description

It was reported that the vns patient was experiencing hoarseness, shortness of breath, and throat pain.The patient¿s asthma had exacerbated at the time.The patient was given steroids and an inhaler and the symptoms resolved.The patient later reported experiencing pain at the lead site and pain from laughing and coughing.The patient also reported discomfort at night and began snoring.The patient and patient's mother reported hearing and engine-like sound coming from the patient's device at night.The patient refused to have her device settings adjusted but noted that she was not using her magnet due to discomfort.Further follow-up revealed that x-rays were later taken and confirmed proper placement of the generator and lead; however, they showed chest wall infection with consolidation of the left lower lobe that was affecting her breathing.The patient is expected to receive antibiotics and a follow-up x-ray.Attempts for additional relevant information were made but have been unsuccessful to date.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 102R
• 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: 3800594
• MDR Text Key: 17387196
• Report Number: 1644487-2014-01217
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 102R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/14/2014
• 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