MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

Model Number 302-20

Device Problems Circuit Failure (1089); Device Inoperable (1663); Low impedance (2285)

Patient Problem Seizures (2063)

Event Date 03/03/2015

Event Type  malfunction  

Event Description

It was reported that the patient was referred for an end of service replacement that took place that day.The patient¿s generator prior to surgery was interrogated and showed ifi-yes.Diagnostics were also taken and resulted in a low impedance of <600 ohms.The patient was doing doing fine and has no increased seizures, so since the ifi=yes flag was seen they decided to replace before it actually gets to eos in case the seizures come back.Patient¿s programming history shows that the impedance has been dropping slowly since implantation suspecting a possible short circuit.The surgeon checked the lead and reported that he did not see anything obvious in terms of abrasions or fluid in lead at the area near the generator.He took out the old generator and replaced with a new generator.He performed the system diagnostics again and got high impedance at 9236 ohms.The surgeon re-inserted the pin and performed diagnostics which again showed a low impedance of <600 ohms.The surgeon performed two more diagnostic results which both showed low impedance but the surgeon decided to not revise the lead since he did not feel comfortable replacing it with just the diagnostic results.Patient was doing well prior to surgery so if there is an issue later on, he will bring them back into surgery.He informed the patient¿s family about his decision also.The explanted generator will not be returned for analysis.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

• 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: 4649309
• MDR Text Key: 5758062
• Report Number: 1644487-2015-04335
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2006
• Device Model Number: 302-20
• Device Lot Number: 011537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2004
• 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: 11 YR