MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 07/10/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.

Event Description

Report received that a patient had an infection at the generator site.It was also reported that the patient was a "picker".The patient's mother stated she noticed redness about a week prior to this report and put a piece of gauze over the incision.The patient was reportedly started on antibiotics.While being consulted for a replacement, it was found that the redness at the incision site was due to a stitch abscess.A review of the device history record indicated the generator had been sterilized properly prior to release for distribution.A review of the device history record indicated the lead had also been sterilized properly prior to release for distribution.The patient's lead and generator were reportedly explanted.No further relevant information has been provided.

• Brand Name: PULSE GEN MODEL 106
• 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: 6803361
• MDR Text Key: 83002683
• Report Number: 1644487-2017-04244
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2017

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/25/2019
• Device Model Number: 106
• Device Lot Number: 204095
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2017
• 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: 16 YR