MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

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

Patient Problems Anaphylactic Shock (1703); Paralysis (1997); Tissue Breakdown (2681)

Event Date 11/07/2017

Event Type  Injury  

Event Description

Patient underwent generator and lead removal due to allergic reaction and extrusion.Patient also experienced vocal cord paralysis, which the surgeon suspects to be related to the allergic reaction.Patient's voice could be barely heard the day after he was implanted.Patient's voice has not improved much since then.The generator was removed because "it literally came out" of patient's chest.Per caregiver, patient has been a good healer in the past and has had multiple procedures without incident.The incision sites did not heal and there was oozing at the sites.The lead wire was sticking out of his chest as well and, so the lead was removed.Per surgeon, the vocal cord paralysis was noted prior to generator removal.The leads were not manipulated at that surgery and were left in the chest.The allergic reaction was present in both the chest and neck sites.A review of device history records showed that both the lead and generator were sterilized prior to distribution.The explanted devices have not been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 7824665
• MDR Text Key: 118521432
• Report Number: 1644487-2018-01512
• 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: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/10/2021
• Device Model Number: 304-20
• Device Lot Number: 204120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• 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: 28 YR