MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Device Expiration Issue (1216); Low Battery (2584)

Patient Problem Seizures (2063)

Event Date 09/24/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

Initially, it was reported that the patient's generator battery was low and the patient needed to undergo generator replacement.The physician's office reported that the generator was at end of service.The patient's mother later reported that the patient's health was deteriorating and the patient was being sent to the emergency room.The patient underwent generator replacement.It was reported that the replacement was due to neos - yes.The physician's office indicated that the patient's caregivers complained of an increase in seizures in august, but that the physician believed it was related to the generator battery being low.The patient's deteriorating condition prior to generator replacement was not reported to the physician.The physician reported that the patient was doing well since generator replacement.The explanted generator has not been received to date.

Event Description

It was reported that the explanting facility does not return explanted devices per protocol; therefore, no product analysis can be performed.

• Brand Name: PULSE GEN MODEL 105
• 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: 5159301
• MDR Text Key: 28602018
• Report Number: 1644487-2015-06165
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2015
• Device Model Number: 105
• Device Lot Number: 3592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2013
• 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: 34 YR