MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Intermittent Continuity (1121)

Patient Problems Bruise/Contusion (1754); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seizures (2063)

Event Date 07/12/2012

Event Type  Injury  

Event Description

It was reported by a nurse that a vns patient had a seizure and felt on her device.Following the fall, the device was working intermittently.X-rays were taken and there was no obvious lead disconnection or breakage.An exploratory surgery was performed on (b)(6) 2012, to disconnect and reconnect the lead, which solved the issue.Further information was received indicating that following the fall, the patient noticed tenderness / bruising over the device and she could felt the device was not working.The patient was seen in clinic on (b)(6) 2012 and it was noticed that the generator has migrated to the right.The patient had pain over the generator area and shoulder and had hematoma on the chest.There were no signs of infection (no redness, no swelling nor heat).It was reported that the patient's generator was regularly checked from 2012 to 2015 and no other issue noted.On (b)(6) 2015, the ifi indicator was detected and the device was replaced on (b)(6) 2016 due to the battery running down.Review of the available programming and diagnostic history showed normal diagnostic results through the adjusted date on (b)(6) 2014.Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution.The explanted device was not returned to the manufacturer for analysis to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 5719870
• MDR Text Key: 47209002
• Report Number: 1644487-2016-01323
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2008
• Device Model Number: 102
• Device Lot Number: 016486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/24/2016
• Initial Date FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2007
• 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 Outcome(s): Required Intervention
• Patient Age: 22 YR