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

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 07/01/2015

Event Type  Injury  

Event Description

It was reported that a patient who is subject to a vns study had presented a left retractile capsulitis.The event started on (b)(6) 2015 and is still ongoing.It was reported that the event was not related to vns implant but possibly related to vns stimulation as the capsulitis occurred on the left shoulder which is the generator side.The event is severe.It is considered as serious as it resulted in a significant disability.Further information was received from the physician indicating that the event began approximately 1 year and half after implant.The capsulitis started a few time after the output current was increased and medication added.Later the physician decided to decrease the output current and to stop the medication added before, but it didn't change anything.System diagnostics were reported to return normal impedance results with dcdc code 2 and near end of service no.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 5404074
• MDR Text Key: 37302553
• Report Number: 1644487-2016-00200
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: 102
• Device Lot Number: 202481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2013
• 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): Disability
• Patient Age: 43 YR