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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384)

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

Event Date 01/08/2018

Event Type  malfunction  

Event Description

High impedance was observed on a patient's device during generator replacement surgery due to low battery.System diagnostics indicated high impedance was present with the existing system.The existing generator was replaced, and high impedance was still present when an additional system diagnostic test was performed, indicating a problem with the existing lead.Using a test resistor, a generator diagnostic test was performed for the explanted generator and returned results within the normal limits, confirming proper function of the generator.The lead was then explanted and replaced with a new lead.The explanted lead and generator have not been received by the manufacturer for analysis to date.

Manufacturer Narrative

Describe event or problem, corrected data: initial report inadvertently did not include updated device disposition.Device available for evaluation?, corrected data: initial report inadvertently did not include updated device disposition.Device evaluated by mfr?, corrected data: initial report inadvertently did not include updated device disposition.

Event Description

The explanted lead and generator were received for analysis.Analysis was approved for the generator.The low battery flag was properly set according to the as-received voltage of the generator.The device performed according to functional specifications.No abnormal performance or any other type of adverse condition was found with the performance of the generator.Analysis has not been approved for the lead to date.

Event Description

Analysis was approved for the lead.Note that since a portion electrode array of the lead was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.Three sets of set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least once.Abraded openings were noted on the outer and inner tubing.A tear was identified in the connector boot, partially exposing the manufacturing id tag.A lead break was identified in the positive coil.Microscopy images of the positive coil show pitting and flat surfaces at the break location.No other anomalies were identified in the returned lead portions.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 7240526
• MDR Text Key: 99002894
• Report Number: 1644487-2018-00146
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/24/2010
• Device Model Number: 302-20
• Device Lot Number: 1892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 03/01/2018; 03/06/2018
• Supplement Dates FDA Received: 03/02/2018; 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2007
• 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: 62 YR