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

Model Number 102

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 03/08/2016

Event Type  Injury  

Event Description

It was reported that the patient was referred for generator replacement surgery.The patient had complained of painful stimulation in his throat.The treating physician acknowledged that the battery indicator was not low, but would need an earlier replacement.The context of the physician's clinic notes suggests that the planned surgery is believed to help address the painful stimulation.Additional information was received from the treating physician indicating that the planned surgery is to preclude a serious injury.Normal mode diagnostics were also reported to be within normal limits.The planned surgery, in addition to address the painful stimulation, is also in anticipation of a future device end of service.The physician was not aware of potential causal or contributory factors to the painful stimulation.The surgery has not occurred to date.No additional pertinent information has been received to date.

Event Description

The patient's generator replacement surgery occurred on (b)(6) 2016.The explanted facility was reported to discard products following surgery, so product return is not expected.No additional pertinent information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 5585300
• MDR Text Key: 42942115
• Report Number: 1644487-2016-00815
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2016

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: 05/31/2010
• Device Model Number: 102
• Device Lot Number: 200843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2008
• 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: 42 YR