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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/01/2013

Event Type  Injury  

Event Description

It was reported that the vns study patient¿s generator was explanted due to pain on (b)(6) 2014.The patient¿s device was programmed to deliver stimulation four times a day.The patient experienced mild pain when moving, sleeping, and touching the generator site for the past year; however the pain intensified in (b)(6) 2014.The device was programmed off per the patient¿s request but the pain persisted.After the generator was removed, the patient¿s pain was resolved.

Manufacturer Narrative

Common device name: type of device product code: this device was implanted to treat rheumatoid arthritis.

• 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: 3705846
• MDR Text Key: 18302501
• Report Number: 1644487-2014-00780
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2014

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: 08/31/2012
• Device Model Number: 102
• Device Lot Number: 2790
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2010
• 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: 41 YR