MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problem No Code Available (3191)

Event Date 11/01/2018

Event Type  Injury  

Event Description

It was reported that after a patient's generator and lead were replaced, the patient noted that the "plug has turned facing up" and the lead was protruding.It was confirmed that it had not broken through the skin.It was also noted that the patient had felt an electrical current described as a "tingle" twice.Follow up with the physician stated that the protrusion was caused by the placement of the device during implant, and the report that the "plug has turned facing up" was not an allegation of migration.Per the physician, there was no device migration and the patient was now just concerned of the now-palpable lead.Non-resorbable sutures were confirmed to have been used to secure the generator during implant.The office was unaware of a tingling sensation or complaint.It was stated that the surgery was both for patient comfort and to preclude a serious injury of preventing exposure of the lead through the skin.No known surgery has occurred to date.No additional, relevant information was received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8441643
• MDR Text Key: 139492599
• Report Number: 1644487-2019-00558
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Other
• Type of Report: Initial
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/18/2020
• Device Model Number: 1000
• Device Lot Number: 204577
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2018
• 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: 56 YR