MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302-20

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem No Code Available (3191)

Event Date 04/19/2016

Event Type  malfunction  

Event Description

Patient was referred for a full revision due to high impedance observed on normal mode diagnostics.A system diagnostic test was not performed and therefore the results are not available.No known surgical interventions have occurred to date.

Event Description

Patient underwent generator and lead replacement on (b)(6) 2016.During the surgery, the generator was replaced prophylactically first.The impedance with the old lead showed > 10,000 ohms, which confirmed that there was a lead discontinuity.The lead was also revised as a result.Impedance was within normal limits (2144 ohms) after the lead was replaced.The explanted generator and lead have not been received to date.

Event Description

The explanted devices were received on 07/29/2016.The device performed according to functional specifications of the current automated final test 102.Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.The lead assembly was returned for analysis due to high impedance and lead fracture allegations.These allegations were not verified within the returned lead portions.Though difficult to state conclusively, the presence of a single setscrew mark at the end tip of the connector pin may be a contributing factor for the reported ¿high impedance¿ allegation.However the reason for this condition or the timing of when it may have occurred is unknown.Based on the location of the one of two sets of setscrew marks on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator ¿+¿ and ¿¿¿ terminals and the lead connector respective contact points (connector ring and connector pin) existed at one time.The lead connector was inserted completely in a pulse generator and no anomalies that could prevent proper insertion were identified.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 typical wear and explant related observations, no anomalies were identified in the returned lead portion.

• Brand Name: LEAD MODEL 302-20
• Type of Device: LEAD
• 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: 5660854
• MDR Text Key: 46573334
• Report Number: 1644487-2016-01048
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2011
• Device Model Number: 302-20
• Device Lot Number: 200910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2008
• 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: 32 YR