MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Septic Shock (2068)

Event Date 03/20/2012

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the infection, extrusion, and wound dehiscence are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that following a generator replacement the patient developed infection, wound dehiscence, and sepsis.The patient was hospitalized first for attempted washout procedure, but ultimately the generator was explanted.The patient was put on antibiotics to address the infection.Generator and lead device history record was reviewed, and no unresolved nonconformances were identified.Both devices were sterilized prior to distribution.Product return and device evaluation is not necessary as the reported infection, wound dehiscence, and sepsis are not related to the functionality or delivery of therapy of the device.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• 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: 10030291
• MDR Text Key: 190050249
• Report Number: 1644487-2020-00672
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/17/2013
• Device Model Number: 104
• Device Lot Number: 201881
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2011
• 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): Other
• Patient Age: 26 YR