MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Low Battery (2584)

Patient Problem No Code Available (3191)

Event Date 08/17/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient recently underwent emergency surgery not related to vns.The patient¿s device subsequently showed a low battery condition during an office visit on (b)(6) 2014.It is believed that during the patient¿s non-vns surgery, electrocautery was used which hit the generator and depleted the battery.An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2014.The explanting facility discarded the explanted device; therefore, no analysis can be performed.

Manufacturer Narrative

Additional information indicates that the event occurred on (b)(6) 2014.

Event Description

Additional information was received stating that the vns patient铠emergency surgery was a shunt malfunction that occurred on (b)(6) 2014.

• Brand Name: PULSE GEN MODEL 103
• 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: 4095602
• MDR Text Key: 4715674
• Report Number: 1644487-2014-02360
• 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,Followup
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: 103
• Device Lot Number: 202240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2012
• 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: 8 YR