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

Model Number 102

Device Problems Failure to Interrogate (1332); Battery Problem (2885)

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

Event Date 12/12/2014

Event Type  malfunction  

Event Description

It was reported that the recently implanted patient's generator was unable to be interrogated.The patient was sent home without the device being interrogated.Troubleshooting was performed which identified that the wand battery was depleted.It is unknown whether or not changing the battery resolved the issue and whether or not the patient has been seen to attempt device interrogation with the new wand battery.No additional relevant information has been received to date.

Event Description

Additional information was received stating that the communication issues had resolved once the programming wand battery was replaced.The patient had since returned to the office and the patient¿s device was successfully interrogated.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• 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: 4398225
• MDR Text Key: 5124983
• Report Number: 1644487-2015-03570
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: 102
• Device Lot Number: 203036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2014
• 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: 38 YR