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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC.PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102   Back to Search Results
Model Number 102
Event Date 03/13/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was initially reported that a pt was having episodes of bradycardia with a heart rate in the 30s and was also experiencing a few episodes of asystole (each about 5 seconds in duration). The cardiologist thought it may possibly be related to the pt's vns device. A company rep went to the pt's next appt and was unable to interrogate the pt's device due to believed end of service. A battery life calculation was performed using the pt's programming history available in the in-house database (current from date of implant to (b) (6) 2009) and it was found that the device may be at end of service. Good faith attempts to obtain add'l info have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section F)
CYBERONICS, INC.
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key1698236
MDR Report Key1658341
Event Key1576158
Report Number1644487-2010-00889
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/13/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date02/29/2008
Device MODEL Number102
Device LOT Number015484
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received03/13/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

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