MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Insufficient Information (3190)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 02/25/2014

Event Type  Injury  

Event Description

The patent had generator pocket revision on (b)(6) 2015.The surgeon moved the generator from the armpit area and into the front chest area below the collarbone.While moving locations, he decided to replace the generator in the process due to the patient's complaint of shocking sensations.The explanted generator was discarded.Therefore, analysis is unable to be performed.

Manufacturer Narrative

Age at time of event, corrected data: the initial report inadvertently reported this data incorrectly.

Event Description

Initially, it was reported that the patient was experiencing a shocking sensation with device stimulation following generator replacement.It was reported that device diagnostics were within normal limits.The physician indicated that the patient may be referred for lead replacement.It was later reported that the patient was referred for generator and lead replacement at the patient's request.No additional relevant information has been received to date.Surgery is planned, but has not occurred to date.

• Brand Name: PULSE GEN MODEL 104
• 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: 4441302
• MDR Text Key: 5456474
• Report Number: 1644487-2015-03680
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/31/2014

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: 06/30/2015
• Device Model Number: 104
• Device Lot Number: 3688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 01/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2013
• 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: 32 YR