MAUDE Adverse Event Report: CYBERONICS, INC. PATIENT ESSENTIALS KIT

Device Problem Use of Device Problem (1670)

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

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that when the patient uses his magnet it does not register.The physician used the office magnet and it registered.The patient was provided a new magnet.The physician reported that no magnet diagnostics were performed and that magnet swiping technique was observed to confirm that it is effective in initiating magnet stimulation.The physician will ask the patient if the magnet can be returned to manufacturer for analysis.The magnet has not been received to date.

Event Description

It was observed that this event should not have been reported initially since this magnet malfunction did not cause or contribute to a serious injury or death.

Manufacturer Narrative

It was observed that this event should not have been reported initially since this magnet malfunction did not cause or contribute to a serious injury or death.

• Brand Name: PATIENT ESSENTIALS KIT
• Type of Device: PATIENT ESSENTIALS KIT
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3800769
• MDR Text Key: 15322031
• Report Number: 1644487-2014-01225
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 08/05/2014
• Initial Date FDA Received: 05/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR