MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Loose or Intermittent Connection (1371); Device Damaged Prior to Use (2284)

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

Event Date 10/10/2014

Event Type  malfunction  

Event Description

Additional information was received that product analysis was completed on the generator.No signs of manipulation of the returned setscrew were present and the septum was not returned for evaluation.The header septum cavity meets specification.Therefore, a root cause for the condition could not be determined.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 3.031 volts shows an ifi=no condition.The data in the diagaccum consumed memory locations revealed that 0.574% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

It was initially reported that the septum plug became loose from a new opened 105 generator.The surgery was completed using another 105 generator.The generator has been returned to the manufacturer for evaluation.Product analysis is planned but has not been completed.Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4220776
• MDR Text Key: 4996664
• Report Number: 1644487-2014-02903
• 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,Followup
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: 105
• Device Lot Number: 3909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2014
• 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: 20 YR