MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the physician the patient had high impedance.It was later reported that patient had surgery on (b)(6) 2015 due to the high impedance observed.During surgery, the physician removed the vns generator from the pocket, removed the lead pin from the vns generator, wiped the lead pin off, re-inserted the lead pin into the vns generator, and tightened.After the lead pin was re-inserted into the vns generator, multiple diagnostics tests were run, both outside and inside the pocket, which showed the impedance was within the acceptable range.

Manufacturer Narrative

Method, results, and conclusions: corrected data: these codes were inadvertently reported incorrectly on the initial mfr.Report.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5166718
• MDR Text Key: 29187874
• Report Number: 1644487-2015-06191
• 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: Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2016
• Device Model Number: 105
• Device Lot Number: 203237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• 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 Age: 13 YR