MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient's device was unable to be communicated with.The physician used two different programming systems that had been working without issue, but the generator was still unable to be communicated with.The patient's generator was able to be palpated and was closer to the midline than in an axillary position.The patient had been cardioverted on (b)(6) 2016 due to atrial fibrillation (not related to vns), and the patient immediately stopped feeling stimulation after the procedure.The patient's generator was implanted on (b)(6) 2016 and programmed on during the surgery without issue.The generator had not been communicated with since implant.Troubleshooting was performed, including ensuring the wand battery was not depleted, the handheld was not plugged into the wall, and two generator hard resets.However, the generator was still unable to be communicated with.The company representative also attempted to communicate with the patient's device on (b)(6) 2016, but was unsuccessful.Another hard reset was performed, but the device was unable to be communicated with.The physician's programming system was confirmed to be functioning properly with a demo generator.Further information was received clarifying that the patient had cardioversion performed on (b)(6) 2016 and also had heart attack (not related to vns) on (b)(6) 2016 with subsequent cardiac catheterization that showed no blockage.System diagnostics showed good lead impedance and proper functionality of the device during implant surgery on (b)(6) 2016.The patient was referred for generator replacement.No surgical intervention has occurred to date.

Event Description

The patient had generator replacement surgery due to the generator not communicating.The explanted generator was discarded.Therefore, no analysis could be performed.

• Brand Name: PULSE GEN MODEL 102
• 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: 5847816
• MDR Text Key: 52063045
• Report Number: 1644487-2016-01747
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2017
• Device Model Number: 102
• Device Lot Number: 203585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2015
• 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: 75 YR