MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Break (1069); Failure to Interrogate (1332)

Patient Problem No Information (3190)

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During the replacement surgery on (b)(6) 2016, the surgeon decided to replace the generator because he used electro-cautery when removing the old battery that resulted in damaging the device.The generator was unable to be interrogated after electro-cautery was used showing that the device had premature end of life.There were no signs of physical damage to the device just battery depletion.The device was discarded after surgery.This event was previously reported on supplemental mdr #1 in mfr report #1644487-2015-06515 on (b)(6) 2016.However, in order to more thoroughly and accurately report the event and suspect device and device information, this initial report was created.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5589312
• MDR Text Key: 44011561
• Report Number: 1644487-2016-00837
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2017
• Device Model Number: 106
• Device Lot Number: 203429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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: 51 YR