MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Battery Problem (2885)

Patient Problems Headache (1880); Seizures (2063); Dizziness (2194)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It was reported that the patient had a generator replacement on (b)(6) 2015.Information obtained on (b)(6) 2015 that the patient was seen on (b)(6) 2015.It was noted that the patient was last seen in (b)(6) 2014 and seizures were well controlled.However, over the last 3-4 weeks she has noticed more frequent seizures.For most of her seizures, she usually has aura, which was described as tingling sensation in hands, followed by difficulties with getting the words out, lasting about a minute.Over the last 3-4 weeks, she had two episodes of generalized tonic-clonic seizures without any warning.The battery was interrogated and showed that the battery is low with ifi-yes.Over the last few months, she has also been complaining of worsening headache with dizziness spells.Attempts for further relevant information have been made but have been unsuccessful to date.The explant generator has not been received to date.

Event Description

The explanted device was discarded after surgery and will not be returned for analysis.

• Brand Name: PULSE GEN MODEL 103
• 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: 5021879
• MDR Text Key: 23723193
• Report Number: 1644487-2015-05580
• 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
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2011
• Device Model Number: 103
• Device Lot Number: 2300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2009
• 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 Outcome(s): Required Intervention
• Patient Age: 36 YR