MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Date 06/17/2016

Event Type  malfunction  

Event Description

The patient had generator replacement surgery on (b)(6) 2016 due to battery depletion.It was identified as the generator was going to be explanted that the header was completely detached from the generator can.The physician stated that the patient is violent and causes harm to himself.The patient's father also reported that the patient often pounds on his chest, which may have caused the header to be broken.There was not excessive manipulation of the generator during the explant surgery.The device history record of the generator was reviewed, and the device passed all functional specifications prior to release.The explanted generator was received on 07/06/2016.Analysis has not been approved to date.

Event Description

Analysis was approved on 07/20/2016.An open can measurement of the battery voltage determined that the battery was depleted.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.There were no tool marks on the can or header, which normally rules out an explant related detachment.There were no dried bodily fluids identified on the can (header area) or header, which normally rules out an implant period related detachment.Therefore, the cause of the header detachment is unknown.The device performed according to functional specifications.Other than the header anomaly, there was no abnormal performance or any other type of adverse condition found with the generator.

• Brand Name: PULSE GEN MODEL 102R
• 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: 5796144
• MDR Text Key: 50427000
• Report Number: 1644487-2016-01592
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/23/2011
• Device Model Number: 102R
• Device Lot Number: 2393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2009
• 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: 29 YR