• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/01/2014
Event Type  Injury  
Event Description

An implant card was received indicating that the vns patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator has been returned to the manufacturer where analysis is currently underway.

 
Event Description

Product analysis was completed and approved for the m103 generator on 12/02/2014. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery voltage showed an ifi = yes condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Clinic notes dated (b)(6) 2014 indicate that the patient's initial seizures were described as the patient would drop down without any warning and would have occasional bladder incontinence with it. It was noted that the patient's usual seizures now are described as the patient sitting and his head turns back and he stops breathing and loses consciousness briefly. It was noted that the patient has a history of grand mal seizures since age 14 years. It was noted that the patient experiences 1-2 seizures per month. The patient was referred for surgery. The relationship of the change in seizures to vns is unknown. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical intervention has been performed to date.

 
Manufacturer Narrative

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 Key4175775
Report Number1644487-2014-02696
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/19/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2013
Device MODEL Number103
Device LOT Number3306
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/11/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/02/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/09/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/15/2014 Patient Sequence Number: 1
-
-