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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 04/12/2012
Event Type  Injury  
Event Description

It was reported that apatient now has a pacemaker implanted. The patient can reportedly no longer use the vns magnet to stop stimulation or it "stops the pacemaker. " the patient planned on following up with her psychiatrists. It is unclear when the patient's arrhythmia first occurred, and the relationship to vns is unknown with the information provided. Attempts for additional information from the psychiatrist have been unsuccessful to date. A review of the patient's programming/diagnostic history was performed with the history available in the in-house database, however there were no diagnostics available.

 
Event Description

The psychiatrist was wondering on (b)(6) 2012 if the patient's device could be disabled, as the patient desired for the device to be turned off. However, the device has not been turned off. It appears that the patient desires for the device to be disabled due to her programmed settings which have been low throughout the implant history.

 
Manufacturer Narrative

The initial report inadvertently did not include that the patient wanted the device turned off.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
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 Key2552987
Report Number1644487-2012-01102
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 04/12/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2008
Device MODEL Number102
Device LOT Number015227
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/09/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/17/2006
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: 04/30/2012 Patient Sequence Number: 1
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