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

Model Number 103

Device Problem High impedance (1291)

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

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that high impedance was observed during the patient's initial implant surgery on (b)(6) 2015.After the new generator was implanted, diagnostics performed with the new generator and old lead out of pocket showed high impedance.The surgeon confirmed that the lead was not nicked during the surgery.The nerve, was irrigated but the diagnostics shill showed high impedance.The lead pin was reinserted into the generator and diagnostics still resulted in high impedance.The lead pin was removed and generator diagnostics with the lead resistor was performed resulting in normal results.The generator was connected to the old lead and high impedance persisted.Finally, the lead was replaced by the surgeon.Additional information was received that the high impedance was observed on system diagnostic test.Normal impedance was received once the lead was replaced.The suspect lead was received on 09/29/2015 due to lead discontinuity.Analysis is underway but has not yet been completed.

Manufacturer Narrative

(b)(4).

Event Description

The lead was returned intact.The (+) white and (-) green electrode ribbons appeared to be stretched and the helices misshaped; indicating the lead assembly had been attempted to be used.The condition of the returned lead assembly is consistent with conditions that typically exist following an attempted implant procedure.No other obvious anomalies were noted except for the two half sets of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator.Continuity checks of the returned lead assembly were performed with no discontinuities identified.Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications.Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the stated allegation of 'high impedance'.Incomplete insertion of the connector pin may have been a potential cause for the observed high impedance condition during the implant of this lead.

• 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: 5150436
• MDR Text Key: 28705814
• Report Number: 1644487-2015-06119
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/06/2016
• Device Model Number: 103
• Device Lot Number: 203155
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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: 2 YR