• 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 102R 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 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 05/31/2014
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2014 note that the patient has experienced different seizures than she's had in the past. It was reported that the patient squinches her eyes closed prior to the spells and her eyes stay closed during. The patient appears to be fighting the spell and then will go into it. Her hands and arms will go forward and if she is laying down they go over her head and she will go limp. It was noted that these last only a few seconds and with in a few minutes she will be back to whatever she was doing. It was noted that the patient is generally incontinent with these spells and they do not occur when she is dancing. It was noted that the patient was seizure free from 01/2013 to 05/30/2014 and that the only change was diazepam was discontinued. Diazepam was resumed and the seizures have continued. The physician reported that the patient has experienced some increase in seizures with a loss of therapy, but that the seizures were not above pre-vns baseline frequency. It was reported that medication changes have helped. The physician does not believe that the discontinuation of diazepam was related to the seizures. The patient has been referred for prophylactic generator replacement. No known surgical intervention has been performed to date.

 
Event Description

It was reported that the patient underwent prophylactic generator replacement. Pre-operative device diagnostics were within normal limits (neos - no). Device diagnostics with the new generator connected to the existing lead were within normal limits. The explanted generator was received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Analysis of the generator was completed on 10/02/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

 
Manufacturer Narrative

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102R
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 Key4027967
Report Number1644487-2014-02076
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2009
Device MODEL Number102R
Device LOT Number017152
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/10/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/02/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/12/2007
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: 08/21/2014 Patient Sequence Number: 1
-
-