MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problems Fluid/Blood Leak (1250); Material Frayed (1262); Device Abrasion From Instrument Or Another Object (1387); Low impedance (2285); Device Contamination with Body Fluid (2317)

Patient Problem No Code Available (3191)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During a generator replacement, the new generator's impedance was 604 ohms, which the surgeon considered low.Preoperatively, on the explanted generator, a dcdc-0 was observed upon diagnostics.The surgeon examined the lead and found that it was frayed.The lead was explanted and replaced.A company representative present at the surgery reported that blood was found in the lead.Replacing the lead resolved the issue of low impedance.Review of the lead device history records confirmed that the lead passed all quality specifications prior to distribution with no non-conformances.Product analysis was performed on the lead.The majority or the lead body, including the lead pins, electrode array, and tie downs, was not returned to the manufacturer.On the portion returned, both the inner and outer lead tubing was found to be abraded with the inner quadfilar coils exposed.Dried bodily fluids were found in the inner and outer lead tubing.There were multiple places along the outer tubing where abrasions were found, indicating possible wear.These findings support the low impedance and fluid leaks reported by the surgeon.The patient's physician reported that patient manipulation or trauma to the lead could have possibly contributed to the lead abrasions.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6053482
• MDR Text Key: 58306072
• Report Number: 1644487-2016-02447
• 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: Physician
• Type of Report: Initial
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2009
• Device Model Number: 302-20
• Device Lot Number: 200197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2006
• 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: 13 YR