MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

Model Number 300-20

Event Date 08/16/2013

Event Type  Malfunction  

Event Description

It was reported that the patient had a full vns replacement surgery on (b)(6) 2013 due to a lead fracture. Device manufacturing records were reviewed. Review of manufacturing records confirmed both the generator and lead passed all functional tests prior to distribution. The explanted devices were returned for product analysis. Visual examination noted tool marks on the pulse generator case and header, most likely associated with manipulation of the device during the explant procedure. No other surface abnormalities were noted on this device. The septum was not cored. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. The lead was returned for the allegation of fracture of leads/explanted/due to lead break/high impedance. The lead assembly was returned in two portions and the electrodes and tie downs were not returned. Due to the condition of the lead as ¿ received, determining the marked connector verses the unmarked connector quadfilar coils could not be made during the visual analysis of the returned 132mm portion. Setscrew marks were observed on the marked and unmarked connector pins, providing evidence of a proper mechanical contact between conductive surfaces of both the generator and connect pin. White deposits were observed on the marked connector boot and what appeared to be remnants of dried body fluids were observed inside the outer silicone tubing in some areas. An abraded opening was observed on the outer silicone tubing approximately 43mm-45mm from the connector bifurcation. A slice mark was observed on the outer tubing and penetrated the outer insulation, but the inner tubing did not appear to be damaged. On the returned 132mm portion what appeared to be remnants of dried body fluids were observed inside the outer silicone tubing in some areas and quadfilar coil 1 appeared to be broken approximately 20mm from the electrode bifurcation. Incisions were made to allow for sem photos. Continuity testing could not be performed during the decontamination procedure because the returned lead was not connected to a generator when received into pa. During the visual analysis of the returned 132mm portion quadfilar coil 1 appeared to be broken. Scanning electron microscopy was performed on the connector end of quadfilar coil 1 coil break (found at 20mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been received.

Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 3347245
• Report Number: 1644487-2013-02692
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/16/2013

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/13/2013
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 12/31/2001
• Device MODEL Number: 300-20
• Device LOT Number: 32266C
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 08/21/2013
• Is The Reporter A Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/16/2013
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 12/29/1999
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial