MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems High impedance (1291); Battery Problem (2885)

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

Event Date 03/10/2014

Event Type  malfunction  

Event Description

It was reported that during generator replacement surgery, high impedance was observed and the patient underwent both generator and lead replacement.Only the explanted generator was returned for analysis.Analysis of generator was completed.The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation.The device performed according to functional specifications.Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.The physician's office reported that the physician would not remember any further information; therefore, no additional relevant information was able to be obtained.

Manufacturer Narrative

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: 3778328
• MDR Text Key: 4356845
• Report Number: 1644487-2014-01132
• 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: Physician
• Type of Report: Initial
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2003
• Device Model Number: 300-20
• Device Lot Number: 2802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2001
• 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: 42 YR