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

Model Number 102

Device Problem Premature Discharge of Battery (1057)

Patient Problem Depression (2361)

Event Date 05/09/2013

Event Type  Injury  

Event Description

On (b)(6) 2015 it was reported that the patient underwent a generator replacement on (b)(6) 2013 due to the patient not feeling like the stimulation was working as he was becoming more depressed again.Good faith attempts for further information from the physician were unsuccessful.It was previously reported that the patient believed the generator was no longer working and the generator was interrogated and found to be near end of life.The explanted generator was returned for product analysis.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.No eri flags were identified during the analysis.

Manufacturer Narrative

• 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: 4538079
• MDR Text Key: 5353004
• Report Number: 1644487-2015-03952
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/28/2015

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: 05/31/2007
• Device Model Number: 102
• Device Lot Number: 013315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2013
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2005
• 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: 46 YR