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

Model Number 102R

Device Problems Break (1069); High impedance (1291); Failure to Interrogate (1332); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2014

Event Type  malfunction  

Event Description

It was reported that during generator replacement for end of service high impedance (>10,000 ohms) was seen with the new generator attached to the existing lead.It was reported that the explanted generator was unable to be interrogated due to end of service; therefore, the high impedance was not observed prior to generator replacement.The lead pins were removed and reinserted into the generator header several times; however, device diagnostics still resulted in high impedance.The surgeon decided to remove the lead and while removing the lead broke and the coils were left on the vagus nerve.A new lead and compatible generator were implanted.Device diagnostics with the new vns system was within normal limits (1,928 ohms).The generator and lead were received for analysis on (b)(4) 2014.Analysis is underway, but has not been completed to date.The physician reported that it is unknown if any patient manipulation or truama occurred that is believed to have caused or contributed to the high impedance.Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description

Analysis of the lead was completed on (b)(4) 2014.Three broken strands were identified in the negative coil; one strand remained intact.Although not conclusive, the three identified broken strands may confirm this to be a contributing factor for the high impedance allegation.Scanning electron microscopy images show that pitting or electroㅔching conditions have occurred at the broken strands location.Also, the appearance of two strands suggests that a stress-induced fracture has occurred on the strands.However, due to metal dissolution and/or mechanical distortion (smoothed surfaces) a conclusive determination of the fracture mechanism cannot be made.The early stages of secondary stress-fracture fractures were noted on the fourth strand.Also, scanning electron microscopy images of the unmarked connector pin show that pitting or electro-etching conditions have occurred on the surfaces of the unmarked connector pin.The exact reason for this condition is unknown.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.Abrasions most likely caused by the presence of a tie-down were identified at approximately 25.5cm from the end of the connector bifurcation.The lead coils are kinked at approximately 0.4cm past the electrode bifurcation.The silicone tubing of the coils has what appear to be punctures at this location.A suspected coil break was identified in three strands of what is believed to be the negative coil at approximately 0.3cm past the electrode bifurcation.The silicone tubing of the negative coil has tubing openings at this location.Abrasions were identified on the silicone tubing of the lead coils past the electrode bifurcation.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portions.Incisions in the silicone tubing were necessary to perform proper inspection of the lead coils.Analysis of the generator was completed on (b)(4) 2014.The module performed according to functional specifications.There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

• Brand Name: PULSE GEN MODEL 102R
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3773528
• MDR Text Key: 15358613
• Report Number: 1644487-2014-01116
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2006
• Device Model Number: 102R
• Device Lot Number: 010657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2004
• 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 Age: 23 YR