MAUDE Adverse Event Report: CYBERONICS - HOUSTON BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem Corroded (1131)

Patient Problems Paralysis (1997); Neck Pain (2433)

Event Date 01/01/2019

Event Type  malfunction  

Event Description

It was reported by the patient that she was experiencing vocal cord paralysis.It was stated that the patient's generator had been removed 16 years previously.An ent informed her that the vocal cord paralysis was due to coil degradation.It was also stated that she had a swollen salivary gland due to cancer (unrelated to vns) that was pressing against the electrodes and causing a pinching pain.The patient wished to have the lead explanted.No relevant surgery is known to have occurred to date.No additional relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8823073
• MDR Text Key: 152086719
• Report Number: 1644487-2019-01435
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2001
• Device Model Number: 300-20
• Device Lot Number: 27779C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/1999
• 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: 59 YR