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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 09/01/2013
Event Type  Injury  
Event Description

Follow up with the physician found that the patient successfully underwent generator replacement on (b)(6) 2013 due to end of service. Since replacement, the patient is no longer vomiting and that all other issues previously mentioned have been resolved.

 
Event Description

Good faith attempts to for return of the patient's explanted generator have been unsuccessful to date.

 
Manufacturer Narrative

Corrected data: supplemental report #1 did not indicate that attempts for return of the explanted generator were unsuccessful. The information has been included in this report.

 
Event Description

Clinic notes dated (b)(6) 2013 note that the patient's mother has noticed a decrease in heartrate into the low 60s and upper 50s. The notes indicate that the patient's heartrate is usually upper 60s and that it may be due to the vns. Clinic notes indicate that the device is near end of service. Attempts to obtain additional information have been unsuccessful to date.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3415683
Report Number1644487-2013-03243
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/18/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2010
Device MODEL Number102
Device LOT Number200733
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/26/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/19/2008
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: 10/17/2013 Patient Sequence Number: 1
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