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

Model Number	102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/01/2015
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: GENERATOR
• Manufacturer (Section D): CYBERONICS; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 5404074
• Report Number: 1644487-2016-00200
• Device Sequence Number: 615196
• Product Code: LYJ
• Combination Product (Y/N): N
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Type of Report: Initial
• Report Date (Section B): 01/08/2016

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: 102
• Device Lot Number: 202481
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2016
• Initial Report FDA Received Date: 02/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 43 YR