• 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 102 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 102 GENERATOR Back to Search Results
Model Number 102
Event Date 01/23/2013
Event Type  Injury  
Event Description

It was reported by the patient's mother that the patient would jerk his head and that his seizure patterns have changed while the vns battery was reportedly depleted. The programming history database was reviewed and it was noted that the physician had the patient set on a 57% duty cycle from date (b)(6) 2011 which is considered as excessive. The physician was contacted, but did not respond to date. Surgery to replace the vns generator is likely, but has not occurred to date.

 
Event Description

Additional information was received which indicated that the patient is taking six different medications which is making him sleep a lot and made him lose a lot of weight. It also indicated that the patient's seizures have decreased after the vns battery depleted and the parent prefers not to revise the vns. Additional information revealed that the patient was cleared for surgery and the surgery date was scheduled on (b)(6) 2013. On (b)(6) 2013, the patient's vns generator was replaced. The explanted generator will not be return as the site does not return explanted products.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2974018
Report Number1644487-2013-00477
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 01/24/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2008
Device MODEL Number102
Device LOT Number016389
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/22/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/27/2006
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: 02/22/2013 Patient Sequence Number: 1
-
-