MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems High impedance (1291); Positioning Problem (3009)

Patient Problems Dyspnea (1816); Tingling (2171)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient had gone to the er on (b)(6) 2016 complaining of dyspnea, coughing, and a tingling sensation in her face and upper extremities.The physician tested the vns and found high impedance.The vns was programmed off and the patient was referred for surgery.The patient underwent surgery to correct the high impedance observed, on (b)(6) 2016.It was noted that the lead pin was not fully inserted into the generator.The lead pin was reinserted; the impedance was checked both outside and inside the generator pocket.Both sets of diagnostics were within normal limits and there was no need for a replacement of either the lead of the generator.

• Brand Name: PULSE GEN MODEL 103
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6019996
• MDR Text Key: 57111010
• Report Number: 1644487-2016-02335
• 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: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2017
• Device Model Number: 103
• Device Lot Number: 4351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2015
• 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: 39 YR