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

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK 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 PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 11/27/2013
Event Type  Injury  
Event Description

A maude event report ((b)(4)) was received indicating that the patient was found unresponsive with a heart rate of 16 bpm. It was reported that the patient was hospitalized and intubated and that the patient was released several days later. It was also noted that the patient has experienced an increase in seizures for the past few months and that the seizures are different than prior seizures. It was reported that the patient no longer experiences her usual aura and no post-ictal state. It was reported that vns induced asystole/bradycardia is suspected. No additional information has been received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
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 Key3651797
Report Number1644487-2014-00556
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/31/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Event Location Other
Date Manufacturer Received01/31/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 02/27/2014 Patient Sequence Number: 1
-
-