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 Inflammation (1932); Muscle Weakness (1967); Discomfort (2330)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had left arm pain after a lead and generator revision.The pain started 6 days post-surgery.The patient was admitted to hospital with worsening neurogenic pain over 2 weeks.He was hyperaesthetic over the left upper limb with no dermatomal distribution.He had mild weakness in the c7 muscles (wrist extension and elbow extension).It was noted that the possible diagnoses were brachial plexopathy related to surgery( bleeding or inflammation), reactive brachial plexopathy, or a new c6/7 disc causing radiculopathy.A ct scan shoed edema around the sternocleidomastoid muscle and mild left c6/7 foramina stenosis.There was no swelling or hematoma around the brachial plexus.The patient was started on gabapentin and showed some improvement in the pain.He left the hospital and was improving.No further relevant information has 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 11931541
• MDR Text Key: 254062688
• Report Number: 1644487-2021-00752
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 304-20
• Device Lot Number: 6742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 51 YR