MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101; GENERATOR

Model Number 101

Device Problems Battery Problem (2885); Device Operates Differently Than Expected (2913); Operating System Becomes Nonfunctional (2996)

Patient Problem Seizures (2063)

Event Date 03/30/2016

Event Type  malfunction  

Event Description

Clinic notes were received 03/08/2016 for a generator replacement referral.It was reported in the notes for a (b)(6) 2016 visit that the patient was experiencing an increase in seizures (reported in mfr report#1644487-2016-01813).An estimate of battery life was requested by the physician, which estimated that on (b)(6) /2015 there was 0.5 years remaining until the battery life indicator would be flagged and was likely depleted at the time of the events.It was clarified in the notes dated 03/30/2016 that when his vns was checked at his last visit, it was found to be non-functioning.The physician indicated it will need to be replaced asap to improve seizure control.Generator replacement surgery occurred on (b)(6) 2016.The company representative who attended the case was able to interrogate the generator and the battery status indicator was neos=no.The explanted generator was reported to have been discarded by the facility.Additional relevant information has not been received to-date.

• Brand Name: PULSE GEN MODEL 101
• 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: 5872507
• MDR Text Key: 52336750
• Report Number: 1644487-2016-01803
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2002
• Device Model Number: 101
• Device Lot Number: 2836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2001
• 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: 28 YR