MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/28/2014

Event Type  malfunction  

Event Description

It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the septum plug from the vns patient¿s replacement generator had detached from the generator.The surgeon was able to reinsert the septum plug, tighten the septum screw, and successfully implant the replacement generator.No complications were occurred during surgery that may have caused or contributed to the detachment of the septum plug.The patient¿s replacement generator was tested with the existing lead outside and inside the generator pocket, and diagnostic results showed lead impedance within normal limits.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• 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: 3824759
• MDR Text Key: 4454332
• Report Number: 1644487-2014-01339
• 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: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: 104
• Device Lot Number: 3723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2013
• 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: 40 YR