MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problem Pain (1994)

Event Date 06/01/2016

Event Type  Injury  

Event Description

Clinic notes were received for a patient¿s generator replacement referral.It was reported in the notes that the patient was experiencing painful stimulation and the feeling like the device was ¿cycling rapidly¿.The notes provide the impedance when checked on (b)(6) 2016 to be within normal limits.It was stated that x-rays showed no indication of a fractured lead.The device was disabled during a visit to the er in the beginning of (b)(6) 2016 and a new medication was added.It was noted the patient has previously failed several aed¿s or had side effects from them.Additional information has not been received to-date.No known surgery has occurred to-date.

Event Description

Revision surgery occurred on (b)(6) 2016.The company representative who attended the surgery provided that after speaking with the patient had been experiencing the pain for the past few months.Lead impedance was within normal limits pre-operatively.During surgery the surgeon inspected the lead and said it was corroded.A full revision was performed and upon removing the lead he noticed that a suture had been pushed through the lead.The explanted generator has not been received by the manufacturer to-date.

Event Description

The explanted devices were received for product analysis on 09/28/2016.Analysis was completed on the returned lead portions 10/11/2016.During the visual analysis a suture was observed sewn through a tie down and outer silicone tubing approximately 266mm from the end of the silicone tubes.The suture did not appear to have penetrated the inner silicone tube.The incision mark and the suture sewn through the outer silicone tubing and the cut ends made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted except for the suture sewn through the outer silicone tubing.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.Analysis was completed for the returned generator 10/18/2016.The septum was not cored.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generatoroutput signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery measured 2.983 volts and shows the intensified follow-up indicator was not set.The downloaded data revealed that 42.695% of the battery had been consumed.Measured battery voltage and consumed capacity parameters were as expected.There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Evaluation codes: the evaluation codes for results and conclusions were inadvertently provided incorrectly on follow-up report #2.

• Brand Name: PULSE GEN MODEL 103
• 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: 5857154
• MDR Text Key: 51490062
• Report Number: 1644487-2016-01784
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2012
• Device Model Number: 103
• Device Lot Number: 201534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2010
• 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: 27 YR