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 Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr?: device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient had dehiscence wound and infection that required vns explant and wound washout surgery.The patient had generator replacement surgery about two and a half months prior.The device history records of the generator and lead were reviewed, and both devices were sterilized according to procedure prior to release.No further relevant information has been received to date.

• 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: 6685454
• MDR Text Key: 79025091
• Report Number: 1644487-2017-04093
• 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: Health Professional
• Type of Report: Initial
• Report Date: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2018
• Device Model Number: 106
• Device Lot Number: 203828
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2016
• 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: 15 YR