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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 05/08/2013
Event Type  Malfunction  
Event Description

It was initially reported that the patient had high impedance at a recent diagnostics. The generator was disabled that day and x-rays were ordered. The patient was implanted a couple weeks prior and the high impedance was found the day the patient came in for an appointment to be turned on. There was no reported manipulation or trauma. No further information was provided. X-rays were received by the manufacturer for review. Based on the x-ray received there was nothing seen that would indicate there was any damage to the generator or lead; however, the presence of a micro-fracture in the lead cannot be ruled out. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. The lead connector pin cannot be confirmed as completely inserted into the generator connector block. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

 
Event Description

Additional information was received that the patient had an impedance of 5500 ohms at a recent appointment. The patient had exploratory surgery and the lead pin was found to not be fully inserted into the generator cavity. Once the pin was fully inserted diagnostics were within normal limits (3856 ohms).

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 103
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 Key3145038
Report Number1644487-2013-01672
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/08/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/04/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2014
Device MODEL Number103
Device LOT Number202296
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/12/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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