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

Model Number 106

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 12/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient underwent generator replacement surgery on (b)(6) 2015.The patient had recently undergone generator replacement on (b)(6) 2015 due to extrusion of the device (mfr.Report # 1644487-2015-06822).Further follow-up revealed that the patient was given a bath following the generator replacement on (b)(6) 2105 and the incision site was saturated with water.The patient then began picking at the site and the device once again extruded.The generator was once again replaced and the group home was instructed to give the patient sponge baths until the incision has healed.Attempts to obtain additional relevant information have been unsuccessful 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: 6864305
• MDR Text Key: 86102498
• Report Number: 1644487-2016-00330
• 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: Physician
• Type of Report: Initial
• Report Date: 01/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2017
• Device Model Number: 106
• Device Lot Number: 4516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2015
• 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: 46 YR